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1. Patient-Reported Outcomes in OlympiA: A Phase III, Randomized, Placebo-Controlled Trial of Adjuvant Olaparib in gBRCA1/2 Mutations and High-Risk Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer.

Author

Ganz, Patricia, Bandos, Hanna, Španić, Tanja, Friedman, Sue, Müller, Volkmar, Kuemmel, Sherko, Delaloge, Suzette, Brain, Etienne, Toi, Masakazu, Yamauchi, Hideko, de Dueñas, Eduardo-M, Armstrong, Anne, Im, Seock-Ah, Song, Chuan-Gui, Zheng, Hong, Sarosiek, Tomasz, Sharma, Priyanka, Geng, Cuizhi, Fu, Peifen, Rhiem, Kerstin, Frauchiger-Heuer, Heike, Wimberger, Pauline, tKint de Roodenbeke, Daphné, Liao, Ning, Goodwin, Annabel, Chakiba-Brugère, Camille, Friedlander, Michael, Lee, Keun, Giacchetti, Sylvie, Takano, Toshimi, Henao-Carrasco, Fernando, Virani, Shamsuddin, Valdes-Albini, Frances, Domchek, Susan, Bane, Charles, McCarron, Edward, Mita, Monica, Rossi, Giovanna, Rastogi, Priya, Fielding, Anitra, Gelber, Richard, Scheepers, Elsemieke, Cameron, David, Garber, Judy, Geyer, Charles, and Tutt, Andrew

Subjects
Female, Humans, BRCA1 Protein, BRCA2 Protein, Breast Neoplasms, Fatigue, Mutation, Nausea, Patient Reported Outcome Measures, Phthalazines, Piperazines, Quality of Life, Receptor, ErbB-2, Vomiting
Abstract

PURPOSE: The OlympiA randomized phase III trial compared 1 year of olaparib (OL) or placebo (PL) as adjuvant therapy in patients with germline BRCA1/2, high-risk human epidermal growth factor receptor 2-negative early breast cancer after completing (neo)adjuvant chemotherapy ([N]ACT), surgery, and radiotherapy. The patient-reported outcome primary hypothesis was that OL-treated patients may experience greater fatigue during treatment. METHODS: Data were collected before random assignment, and at 6, 12, 18, and 24 months. The primary end point was fatigue, measured with the Functional Assessment of Chronic Illness Therapy-Fatigue scale. Secondary end points, assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 item, included nausea and vomiting (NV), diarrhea, and multiple functional domains. Scores were compared between treatment groups using mixed model for repeated measures. Two-sided P values

Published
2024

2. Clinical effectiveness and safety of olaparib in BRCA-mutated, HER2-negative metastatic breast cancer in a real-world setting: final analysis of LUCY

Author

Balmaña, Judith, Fasching, Peter A., Couch, Fergus J., Delaloge, Suzette, Labidi-Galy, Intidhar, O’Shaughnessy, Joyce, Park, Yeon Hee, Eisen, Andrea F., You, Benoit, Bourgeois, Hughes, Gonçalves, Anthony, Kemp, Zoe, Swampillai, Angela, Jankowski, Tomasz, Sohn, Joo Hyuk, Poddubskaya, Elena, Mukhametshina, Guzel, Aksoy, Sercan, Timcheva, Constanta V., Park-Simon, Tjoung-Won, Antón-Torres, Antonio, John, Ellie, Baria, Katherine, Gibson, Isabel, and Gelmon, Karen A.

Published
2024
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3. Acyl-coenzyme a binding protein (ACBP) - a risk factor for cancer diagnosis and an inhibitor of immunosurveillance

Author

Montégut, Léa, Liu, Peng, Zhao, Liwei, Pérez-Lanzón, María, Chen, Hui, Mao, Misha, Zhang, Shuai, Derosa, Lisa, Naour, Julie Le, Lambertucci, Flavia, Mingoia, Silvia, Nogueira-Recalde, Uxía, Mena-Osuna, Rafael, Herranz-Montoya, Irene, Djouder, Nabil, Baulande, Sylvain, Pan, Hui, Joseph, Adrien, Messaoudene, Meriem, Routy, Bertrand, Fidelle, Marine, Ahmed, Tarek Ben, Caron, Olivier, Busson, Pierre, Boulate, David, Deschasaux-Tanguy, Mélanie, Arnault, Nathalie, Pol, Jonathan G., Piaggio, Eliane, Touvier, Mathilde, Zitvogel, Laurence, Delaloge, Suzette, Martins, Isabelle, and Kroemer, Guido

Published
2024
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6. Dynamics of Long-Term Patient-Reported Quality of Life and Health Behaviors After Adjuvant Breast Cancer Chemotherapy

Author

Di Meglio, Antonio, Havas, Julie, Gbenou, Arnauld S, Martin, Elise, El-Mouhebb, Mayssam, Pistilli, Barbara, Menvielle, Gwenn, Dumas, Agnes, Everhard, Sibille, Martin, Anne-Laure, Cottu, Paul H, Lerebours, Florence, Coutant, Charles, Lesur, Anne, Tredan, Olivier, Soulie, Patrick, Vanlemmens, Laurence, Joly, Florence, Delaloge, Suzette, Ganz, Patricia A, André, Fabrice, Partridge, Ann H, Jones, Lee W, Michiels, Stefan, and Vaz-Luis, Ines

Subjects
Breast Cancer, Prevention, Clinical Research, Behavioral and Social Science, Cancer, Good Health and Well Being, Breast Neoplasms, Chemotherapy, Adjuvant, Female, Health Behavior, Humans, Patient Reported Outcome Measures, Quality of Life, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeWe aimed to characterize long-term quality of life (QOL) trajectories among patients with breast cancer treated with adjuvant chemotherapy and to identify related patterns of health behaviors.MethodsFemale stage I-III breast cancer patients receiving chemotherapy in CANTO (CANcer TOxicity; ClinicalTrials.gov identifier: NCT01993498) were included. Trajectories of QOL (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 Summary Score) and associations with trajectory group membership were identified by iterative estimations of group-based trajectory models and multivariable multinomial logistic regression, respectively.ResultsFour trajectory groups were identified (N = 4,131): excellent (51.7%), very good (31.7%), deteriorating (10.0%), and poor (6.6%) QOL. The deteriorating trajectory group reported fairly good baseline QOL (mean [95% CI], 78.3/100 [76.2 to 80.5]), which significantly worsened at year-1 (58.1/100 [56.4 to 59.9]) and never recovered to pretreatment values through year-4 (61.1/100 [59.0 to 63.3]) postdiagnosis. Healthy behaviors were associated with better performing trajectory groups. Obesity (adjusted odds ratio [aOR] v lean, 1.51 [95% CI, 1.28 to 1.79]; P < .0001) and current smoking (aOR v never, 1.52 [95% CI, 1.27 to 1.82]; P < .0001) at diagnosis were associated with membership to the deteriorating group, which was also characterized by a higher prevalence of patients with excess body weight and insufficient physical activity through year-4 and by frequent exposure to tobacco smoking during chemotherapy. Additional factors associated with membership to the deteriorating group included younger age (aOR, 1-year decrement 1.01 [95% CI, 1.01 to 1.02]; P = .043), comorbidities (aOR v no, 1.22 [95% CI, 1.06 to 1.40]; P = .005), lower income (aOR v wealthier households, 1.21 [95% CI, 1.07 to 1.37]; P = .002), and endocrine therapy (aOR v no, 1.14 [95% CI, 1.01 to 1.30]; P = .047).ConclusionThis latent-class analysis identified some patients with upfront poor QOL and a high-risk cluster with severe, persistent postchemotherapy QOL deterioration. Screening relevant patient-level characteristics may inform tailored interventions to mitigate the detrimental impact of chemotherapy and preserve QOL, including early addressal of behavioral concerns and provision of healthy lifestyle support programs.

Published
2022

7. Long-Term Longitudinal Patterns of Patient-Reported Fatigue After Breast Cancer: A Group-Based Trajectory Analysis

Author

Vaz-Luis, Ines, Di Meglio, Antonio, Havas, Julie, El-Mouhebb, Mayssam, Lapidari, Pietro, Presti, Daniele, Soldato, Davide, Pistilli, Barbara, Dumas, Agnes, Menvielle, Gwenn, Charles, Cecile, Everhard, Sibille, Martin, Anne-Laure, Cottu, Paul H, Lerebours, Florence, Coutant, Charles, Dauchy, Sarah, Delaloge, Suzette, Lin, Nancy U, Ganz, Patricia A, Partridge, Ann H, André, Fabrice, and Michiels, Stefan

Subjects
Prevention, Clinical Research, Cancer, Breast Cancer, Rehabilitation, Breast Neoplasms, Fatigue, Female, Humans, Longitudinal Studies, Patient Reported Outcome Measures, Prospective Studies, Quality of Life, Survivors, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeFatigue is recognized as one of the most burdensome and long-lasting adverse effects of cancer and cancer treatment. We aimed to characterize long-term fatigue trajectories among breast cancer survivors.MethodsWe performed a detailed longitudinal analysis of fatigue using a large ongoing national prospective clinical study (CANcer TOxicity, ClinicalTrials.gov identifier: NCT01993498) of patients with stage I-III breast cancer treated from 2012 to 2015. Fatigue was assessed at diagnosis and year 1, 2, and 4 postdiagnosis. Baseline clinical, sociodemographic, behavioral, tumor-related, and treatment-related characteristics were available. Trajectories of fatigue and risk factors of trajectory-group membership were identified by iterative estimates of group-based trajectory models.ResultsThree trajectory groups were identified for severe global fatigue (n = 4,173). Twenty-one percent of patients were in the high-risk group, having risk estimates of severe global fatigue of 94.8% (95% CI, 86.6 to 100.0) at diagnosis and 64.6% (95% CI, 59.2 to 70.1) at year 4; 19% of patients clustered in the deteriorating group with risk estimates of severe global fatigue of 13.8% (95% CI, 6.7 to 20.9) at diagnosis and 64.5% (95% CI, 57.3 to 71.8) at year 4; 60% were in the low-risk group with risk estimates of 3.6% (95% CI, 2.5 to 4.7) at diagnosis and 9.6% (95% CI, 7.5 to 11.7) at year 4. The distinct dimensions of fatigue clustered in different trajectory groups than those identified by severe global fatigue, being differentially affected by sociodemographic, clinical, and treatment-related factors.ConclusionOur findings highlight the multidimensional nature of cancer-related fatigue and the complexity of its risk factors. This study helps to identify patients with increased risk of severe fatigue and to inform personalized interventions to ameliorate this problem.

Published
2022

8. Development and Validation of a Predictive Model of Severe Fatigue After Breast Cancer Diagnosis: Toward a Personalized Framework in Survivorship Care

Author

Di Meglio, Antonio, Havas, Julie, Soldato, Davide, Presti, Daniele, Martin, Elise, Pistilli, Barbara, Menvielle, Gwenn, Dumas, Agnes, Charles, Cecile, Everhard, Sibille, Martin, Anne-Laure, Coutant, Charles, Tarpin, Carole, Vanlemmens, Laurence, Levy, Christelle, Rigal, Olivier, Delaloge, Suzette, Lin, Nancy U, Ganz, Patricia A, Partridge, Ann H, André, Fabrice, Michiels, Stefan, and Vaz-Luis, Ines

Subjects
Behavioral and Social Science, Clinical Research, Breast Cancer, Cancer, Prevention, Good Health and Well Being, Breast Neoplasms, Cancer Survivors, Female, Humans, Quality of Life, Survivors, Survivorship, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeFatigue is common and troublesome among breast cancer survivors; however, limited tools exist to predict its risk.Patients and methodsParticipants with stage I-III breast cancer were prospectively included from CANTO (ClinicalTrials.gov identifier: NCT01993498), collecting longitudinal data at diagnosis (before the initiation of any cancer treatment) and 1 (T1), 2 (T2), and 4 (T3) years after diagnosis. The main outcome was severe global fatigue at T2 (score ≥ 40/100, European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30). Analyses at T3 were exploratory. Secondary outcomes included physical, emotional, and cognitive fatigue (EORTC Quality of Life Questionnaire-FA12). Multivariable logistic regression models retained associations with severe fatigue by bootstrapped Augmented Backward Elimination. Validation methods included 10-fold internal cross-validation, overoptimism-corrected area under the receiver operating characteristic curves, and external validation.ResultsAmong 5,640, 5,000, and 3,400 patients at T1, T2, and T3, respectively, the prevalence of post-treatment severe global fatigue was 35.6%, 34.0%, and 31.5% in the development cohort. Retained risk factors for severe global fatigue at T2 were severe pretreatment fatigue (adjusted odds ratio v no 3.191 [95% CI, 2.704 to 3.767]); younger age (for 1-year decrement 1.015 [1.009 to 1.022]), higher body mass index (for unit increment 1.025 [1.012 to 1.038]), current smoking behavior (v never 1.552 [1.291 to 1.866]), worse anxiety (v noncase 1.265 [1.073 to 1.492]), insomnia (for unit increment 1.005 [1.003 to 1.007]), and pain at diagnosis (for unit increment 1.014 [1.010 to 1.017]), with an area under the receiver operating characteristic curve of 0.73 (95% CI, 0.72 to 0.75). Receipt of hormonal therapy was a risk factor for severe fatigue at T3 (v no 1.448 [1.165 to 1.799]). Dimension-specific risk factors included body mass index for physical fatigue and emotional distress for emotional and cognitive fatigue.ConclusionWe propose a predictive model to assess fatigue among breast cancer survivors, within a personalized survivorship care framework. This may help clinicians to provide early management interventions or to correct modifiable risk factors and offer more tailored monitoring and education to patients at risk of severe post-treatment fatigue.

Published
2022

10. Buffy coat signatures of breast cancer risk in a prospective cohort study

Author

Chung, Felicia Fei-Lei, Maldonado, Sandra González, Nemc, Amelie, Bouaoun, Liacine, Cahais, Vincent, Cuenin, Cyrille, Salle, Aurelie, Johnson, Theron, Ergüner, Bekir, Laplana, Marina, Datlinger, Paul, Jeschke, Jana, Weiderpass, Elisabete, Kristensen, Vessela, Delaloge, Suzette, Fuks, François, Risch, Angela, Ghantous, Akram, Plass, Christoph, Bock, Christoph, Kaaks, Rudolf, and Herceg, Zdenko

Published
2023
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11. Association between progression-free survival and overall survival in women receiving first-line treatment for metastatic breast cancer: evidence from the ESME real-world database

Author

Courtinard, Coralie, Gourgou, Sophie, Jacot, William, Carton, Matthieu, Guérin, Olivier, Vacher, Laure, Bertaut, Aurélie, Le Deley, Marie-Cécile, Pérol, David, Marino, Patricia, Levy, Christelle, Uwer, Lionel, Perrocheau, Geneviève, Schiappa, Renaud, Bachelot, Florence, Parent, Damien, Breton, Mathias, Petit, Thierry, Filleron, Thomas, Loeb, Agnès, Mathoulin-Pélissier, Simone, Robain, Mathieu, Delaloge, Suzette, and Bellera, Carine

Published
2023
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12. AMEERA-5: a randomized, double-blind phase 3 study of amcenestrant plus palbociclib versus letrozole plus palbociclib for previously untreated ER+/HER2– advanced breast cancer

Author

Bardia, Aditya, Cortes, Javier, Hurvitz, Sara A, Delaloge, Suzette, Iwata, Hiroji, Shao, Zhi-Ming, Kanagavel, Dheepak, Cohen, Patrick, Liu, Qianying, Cartot-Cotton, Sylvaine, Pelekanou, Vasiliki, and O’Shaughnessy, Joyce

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Breast Cancer, Aging, Clinical Research, Clinical Trials and Supportive Activities, Cancer, Estrogen, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, amcenestrant, endocrine therapy, ER-positive, HER2-negative, metastatic breast cancer, selective estrogen receptor degrader, ER-positive/HER2-negative, Oncology and carcinogenesis
Abstract

BackgroundFor estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC), the current standard first-line treatment includes an aromatase inhibitor in combination with a cyclin-dependent kinase 4/6 inhibitor. When resistance occurs, often related to the occurrence of ESR1 mutations, selective estrogen receptor modulators or degraders (SERDs) may be used, alone or in combination regimens. Amcenestrant (SAR439859), an optimized oral SERD, has shown clinical antitumor activity in combination with palbociclib in patients with ER+/HER2- ABC and, as monotherapy, in patients with and without ESR1 mutations. Here, we describe the study design of AMEERA-5, an ongoing, prospective, phase 3, randomized, double-blind, multinational study comparing the efficacy and safety of amcenestrant plus palbociclib versus letrozole plus palbociclib in patients with advanced (locoregional recurrent or metastatic) ER+/HER2- breast cancer.MethodsPatients are pre-/postmenopausal women and men with no prior systemic therapy for ABC. The planned enrollment is 1066 patients. Patients are randomized 1:1 to either amcenestrant 200 mg plus palbociclib 125 mg or letrozole 2.5 mg plus palbociclib 125 mg. Amcenestrant, letrozole, and their matching placebos are taken once daily continuously; palbociclib is taken once daily for 21 days, followed by 7 days off-treatment for a 28-day cycle. Treatment continues until disease progression, unacceptable toxicity, or decision to stop treatment. Pre-/perimenopausal women and men receive goserelin subcutaneously. Randomization is stratified by de novo metastatic disease, menopausal status, and visceral metastases. The primary endpoint is progression-free survival. The key secondary endpoint is overall survival; others are safety, pharmacokinetics, and quality of life.ConclusionsAMEERA-5 is evaluating the efficacy and safety of amcenestrant in combination with palbociclib as first-line therapy in pre-/postmenopausal women and men with ER+/HER2- ABC.Clinicaltrials identifierNCT04478266.

Published
2022

13. Pattern and risk factors of isolated local relapse among women with hormone receptor-positive and HER2-negative breast cancer and lymph node involvement: 10-year follow-up analysis of the PACS 01 and PACS 04 trials

Author

Rassy, Elie, Filleron, Thomas, Viansone, Alessandro, Lacroix-Triki, Magali, Rivera, Sofia, Desmoulins, Isabelle, Serin, Daniel, Canon, Jean Luc, Campone, Mario, Gonçalves, Anthony, Levy, Christelle, Cottu, Paul, Petit, Thierry, Eymard, Jean-Christophe, Debled, Marc, Bachelot, Thomas, Dalenc, Florence, Roca, Lise, Lemonnier, Jerôme, Delaloge, Suzette, and Pistilli, Barbara

Published
2023
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14. Change in the value of work after breast cancer: evidence from a prospective cohort

Author

Caumette, Elsa, Di Meglio, Antonio, Vaz-Luis, Inès, Charles, Cécile, Havas, Julie, de Azua, Garazi Ruiz, Martin, Elise, Vanlemmens, Laurence, Delaloge, Suzette, Everhard, Sibille, Martin, Anne-Laure, Merimeche, Asma Dhaini, Rigal, Olivier, Coutant, Charles, Fournier, Marion, Jouannaud, Christelle, Soulie, Patrick, Cottu, Paul-Henri, Tredan, Olivier, Menvielle, Gwenn, and Dumas, Agnès

Published
2023
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15. First-line real-world treatment patterns and survival outcomes in women younger or older than 40 years with metastatic breast cancer in the real-life multicenter French ESME cohort

Author

Galvin, Angéline, Courtinard, Coralie, Bouteiller, Fanny, Gourgou, Sophie, Dalenc, Florence, Jacot, William, Arnedos, Monica, Bailleux, Caroline, Dieras, Véronique, Petit, Thierry, Emile, George, Dubray-Longeras, Pascale, Frenel, Jean-Sébastien, Bachelot, Thomas, Mailliez, Audrey, Brain, Etienne, Desmoulins, Isabelle, Massard, Vincent, Patsouris, Anne, Goncalves, Anthony, Grinda, Thomas, Delaloge, Suzette, and Bellera, Carine

Published
2024
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16. Biomarker Analysis of the Phase III NALA Study of Neratinib + Capecitabine versus Lapatinib + Capecitabine in Patients with Previously Treated Metastatic Breast CancerBiomarker Analysis of the Phase III NALA Study in HER2+ MBC

Author

Saura, Cristina, Matito, Judit, Oliveira, Mafalda, Wildiers, Hans, Brufksy, Adam M, Waters, Simon H, Hurvitz, Sara A, Moy, Beverly, Kim, Sung-Bae, Gradishar, William J, Queiroz, Geraldo Silva, Cronemberger, Eduardo, Wallweber, Gerald J, Bebchuk, Judith, Keyvanjah, Kiana, Lalani, Alshad S, Bryce, Richard, Vivancos, Ana, Eli, Lisa D, and Delaloge, Suzette

Subjects
Breast Cancer, Cancer, Detection, screening and diagnosis, 4.2 Evaluation of markers and technologies, Antineoplastic Combined Chemotherapy Protocols, Biomarkers, Tumor, Breast Neoplasms, Capecitabine, Correlation of Data, Female, Humans, Lapatinib, Neoplasm Metastasis, Quinolines, Retreatment, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeNeratinib plus capecitabine (N+C) demonstrated significant progression-free survival (PFS) benefit in NALA (NCT01808573), a randomized phase III trial comparing N+C with lapatinib + capecitabine (L+C) in 621 patients with HER2-positive (HER2+) metastatic breast cancer (MBC) who had received ≥2 prior HER2-directed regimens in the metastatic setting. We evaluated correlations between exploratory biomarkers and PFS.Patients and methodsSomatic mutations were evaluated by next-generation sequencing on primary or metastatic samples. HER2 protein expression was evaluated by central IHC, H-score, and VeraTag/HERmark. p95 expression (truncated HER2) was measured by VeraTag. HRs were estimated using unstratified Cox proportional hazards models.ResultsFour hundred and twenty samples had successful sequencing: 34.0% had PIK3CA mutations and 5.5% had HER2 (ERBB2) mutations. In the combined patient populations, PIK3CA mutations trended toward shorter PFS [wild-type vs. mutant, HR = 0.81; 95% confidence interval (CI), 0.64-1.03], whereas HER2 mutations trended toward longer PFS [HR = 1.69 (95% CI, 0.97-3.29)]. Higher HER2 protein expression was associated with longer PFS [IHC 3+ vs. 2+, HR = 0.67 (0.54-0.82); H-score ≥240 versus

Published
2021

17. Efficacy of Neratinib Plus Capecitabine in the Subgroup of Patients with Central Nervous System Involvement from the NALA Trial

Author

Hurvitz, Sara A, Saura, Cristina, Oliveira, Mafalda, Trudeau, Maureen E, Moy, Beverly, Delaloge, Suzette, Gradishar, William, Kim, Sung‐Bae, Haley, Barbara, Ryvo, Larisa, Dai, Ming‐Shen, Milovanov, Vladimir, Alarcón, Jesús, Kalmadi, Sujith, Cronemberger, Eduardo, Souza, Cristiano, Landeiro, Luciana, Bose, Ron, Bebchuk, Judith, Kabbinavar, Fairooz, Bryce, Richard, Keyvanjah, Kiana, and Brufsky, Adam M

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Cancer, Breast Cancer, Brain Disorders, Neurosciences, Clinical Trials and Supportive Activities, Clinical Research, Comparative Effectiveness Research, Prevention, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Capecitabine, Central Nervous System, Female, Humans, Quinolines, Receptor, ErbB-2, Treatment Outcome, Central nervous system neoplasms, Lapatinib, Neratinib, Receptor, ErbB-2, Receptor, erbB-2, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundNeratinib has efficacy in central nervous system (CNS) metastases from HER2-positive metastatic breast cancer (MBC). We report outcomes among patients with CNS metastases at baseline from the phase III NALA trial of neratinib plus capecitabine (N + C) versus lapatinib plus capecitabine (L + C).Materials and methodsNALA was a randomized, active-controlled trial in patients who received two or more previous HER2-directed regimens for HER2-positive MBC. Patients with asymptomatic/stable brain metastases (treated or untreated) were eligible. Patients were assigned to N + C (neratinib 240 mg per day, capecitabine 750 mg/m2 twice daily) or L + C (lapatinib 1,250 mg per day, capecitabine 1,000 mg/m2 twice daily) orally. Independently adjudicated progression-free survival (PFS), overall survival (OS), and CNS endpoints were considered.ResultsOf 621 patients enrolled, 101 (16.3%) had known CNS metastases at baseline (N + C, n = 51; L + C, n = 50); 81 had received prior CNS-directed radiotherapy and/or surgery. In the CNS subgroup, mean PFS through 24 months was 7.8 months with N + C versus 5.5 months with L + C (hazard ratio [HR], 0.66; 95% confidence interval [CI], 0.41-1.05), and mean OS through 48 months was 16.4 versus 15.4 months (HR, 0.90; 95% CI, 0.59-1.38). At 12 months, cumulative incidence of interventions for CNS disease was 25.5% for N + C versus 36.0% for L + C, and cumulative incidence of progressive CNS disease was 26.2% versus 41.6%, respectively. In patients with target CNS lesions at baseline (n = 32), confirmed intracranial objective response rates were 26.3% and 15.4%, respectively. No new safety signals were observed.ConclusionThese analyses suggest improved PFS and CNS outcomes with N + C versus L + C in patients with CNS metastases from HER2-positive MBC.Implications for practiceIn a subgroup of patients with central nervous system (CNS) metastases from HER2-positive breast cancer after two or more previous HER2-directed regimens, the combination of neratinib plus capecitabine was associated with improved progression-free survival and CNS outcomes compared with lapatinib plus capecitabine. These findings build on previous phase II and III studies describing efficacy of neratinib in the prevention and treatment of CNS metastases, and support a role for neratinib as a systemic treatment option in the management of patients with HER2-positive brain metastases following antibody-based HER2-directed therapies.

Published
2021

18. Neratinib + capecitabine sustains health-related quality of life in patients with HER2-positive metastatic breast cancer and ≥ 2 prior HER2-directed regimens

Author

Moy, Beverly, Oliveira, Mafalda, Saura, Cristina, Gradishar, William, Kim, Sung-Bae, Brufsky, Adam, Hurvitz, Sara A, Ryvo, Larisa, Fagnani, Daniele, Kalmadi, Sujith, Silverman, Paula, Delaloge, Suzette, Alarcon, Jesus, Kwong, Ava, Lee, Keun Seok, Ang, Peter Cher Siang, Ow, Samuel Guan Wei, Chu, Sung-Chao, Bryce, Richard, Keyvanjah, Kiana, Bebchuk, Judith, Zhang, Bo, Oestreicher, Nina, Bose, Ron, and Chan, Nancy

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Breast Cancer, Cancer, Clinical Trials and Supportive Activities, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Capecitabine, Female, Humans, Quality of Life, Quinolines, Receptor, ErbB-2, Neratinib, Metastatic breast cancer, Health-related quality of life, HER2-positive, Receptor, erbB-2, Clinical Sciences, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

PurposeTo characterize health-related quality of life (HRQoL) in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) from the NALA phase 3 study.MethodsIn NALA (NCT01808573), patients were randomized 1:1 to neratinib + capecitabine (N + C) or lapatinib + capecitabine (L + C). HRQoL was assessed using seven prespecified scores from the European Organisation for Research and Treatment of Cancer Quality Of Life Questionnaire core module (QLQ-C30) and breast cancer-specific questionnaire (QLQ-BR23) at baseline and every 6 weeks. Descriptive statistics summarized scores over time, mixed models evaluated differences between treatment arms, and Kaplan-Meier methods were used to assess time to deterioration in HRQoL scores of ≥ 10 points.ResultsOf the 621 patients randomized in NALA, patients were included in the HRQoL analysis if they completed baseline and at least one follow-up questionnaire. The summary, global health status, physical functioning, fatigue, constipation, and systemic therapy side effects scores were stable over time with no persistent differences between treatment groups. There were no differences in time to deterioration (TTD) for the QLQ-C30 summary score between treatment arms; the hazard ratio (HR) for N + C vs. L + C was 0.94 (95% CI 0.63-1.40). Only the diarrhea score worsened significantly more in the N + C arm as compared to the L + C arm, and this remained over time (HR for TTD for N + C vs. L + C was 1.71 [95% CI 1.32-2.23]).ConclusionIn NALA, patients treated with N + C maintained their global HRQoL over time, despite a worsening of the diarrhea-related scores. These results may help guide optimal treatment selection for HER2-positive MBC.

Published
2021

19. Real-world clinical and survival outcomes of patients with early relapsed triple-negative breast cancer from the ESME national cohort

Author

Grinda, Thomas, Antoine, Alison, Jacot, William, Cottu, Paul-Henri, de la Motte Rouge, Thibault, Frenel, Jean-Sébastien, Mailliez, Audrey, Dalenc, Florence, Goncalves, Anthony, Clatot, Florian, Mouret Reynier, Marie-Ange, Levy, Christelle, Ferrero, Jean-Marc, Desmoulins, Isabelle, Uwer, Lionel, Petit, Thierry, Jouannaud, Christelle, Arnedos, Monica, Chevrot, Michaël, Courtinard, Coralie, Tredan, Olivier, Brain, Etienne, Pérol, David, Pistilli, Barbara, and Delaloge, Suzette

Published
2023
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20. Personalized early detection and prevention of breast cancer: ENVISION consensus statement

Author

Pashayan, Nora, Antoniou, Antonis C, Ivanus, Urska, Esserman, Laura J, Easton, Douglas F, French, David, Sroczynski, Gaby, Hall, Per, Cuzick, Jack, Evans, D Gareth, Simard, Jacques, Garcia-Closas, Montserrat, Schmutzler, Rita, Wegwarth, Odette, Pharoah, Paul, Moorthie, Sowmiya, De Montgolfier, Sandrine, Baron, Camille, Herceg, Zdenko, Turnbull, Clare, Balleyguier, Corinne, Rossi, Paolo Giorgi, Wesseling, Jelle, Ritchie, David, Tischkowitz, Marc, Broeders, Mireille, Reisel, Dan, Metspalu, Andres, Callender, Thomas, de Koning, Harry, Devilee, Peter, Delaloge, Suzette, Schmidt, Marjanka K, and Widschwendter, Martin

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Comparative Effectiveness Research, Prevention, Cancer, Aging, Breast Cancer, 4.1 Discovery and preclinical testing of markers and technologies, Detection, screening and diagnosis, Good Health and Well Being, Breast Neoplasms, Consensus, Early Detection of Cancer, Evidence-Based Medicine, Female, Genetic Predisposition to Disease, Humans, Mass Screening, Precision Medicine, Oncology and carcinogenesis
Abstract

The European Collaborative on Personalized Early Detection and Prevention of Breast Cancer (ENVISION) brings together several international research consortia working on different aspects of the personalized early detection and prevention of breast cancer. In a consensus conference held in 2019, the members of this network identified research areas requiring development to enable evidence-based personalized interventions that might improve the benefits and reduce the harms of existing breast cancer screening and prevention programmes. The priority areas identified were: 1) breast cancer subtype-specific risk assessment tools applicable to women of all ancestries; 2) intermediate surrogate markers of response to preventive measures; 3) novel non-surgical preventive measures to reduce the incidence of breast cancer of poor prognosis; and 4) hybrid effectiveness-implementation research combined with modelling studies to evaluate the long-term population outcomes of risk-based early detection strategies. The implementation of such programmes would require health-care systems to be open to learning and adapting, the engagement of a diverse range of stakeholders and tailoring to societal norms and values, while also addressing the ethical and legal issues. In this Consensus Statement, we discuss the current state of breast cancer risk prediction, risk-stratified prevention and early detection strategies, and their implementation. Throughout, we highlight priorities for advancing each of these areas.

Published
2020

21. Publisher Correction: Personalized early detection and prevention of breast cancer: ENVISION consensus statement

Author

Pashayan, Nora, Antoniou, Antonis C, Ivanus, Urska, Esserman, Laura J, Easton, Douglas F, French, David, Sroczynski, Gaby, Hall, Per, Cuzick, Jack, Evans, D Gareth, Simard, Jacques, Garcia-Closas, Montserrat, Schmutzler, Rita, Wegwarth, Odette, Pharoah, Paul, Moorthie, Sowmiya, De Montgolfier, Sandrine, Baron, Camille, Herceg, Zdenko, Turnbull, Clare, Balleyguier, Corinne, Rossi, Paolo Giorgi, Wesseling, Jelle, Ritchie, David, Tischkowitz, Marc, Broeders, Mireille, Reisel, Dan, Metspalu, Andres, Callender, Thomas, de Koning, Harry, Devilee, Peter, Delaloge, Suzette, Schmidt, Marjanka K, and Widschwendter, Martin

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Cancer, Good Health and Well Being, Oncology and carcinogenesis
Abstract

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Published
2020

22. Outcomes of patients with HER2-negative metastatic breast cancer after platinum- and non-platinum-based first-line chemotherapy among patients with and without pathogenic germline BRCA1/2 mutations

Author

Jacot, William, Lusque, Amélie, Vicier, Cécile, Mailliez, Audrey, de La Motte Rouge, Thibault, Cabel, Luc, Levy, Christelle, Patsouris, Anne, Desmoulins, Isabelle, Uwer, Lionel, Thery, Jean-Christophe, Robain, Mathieu, Caron, Olivier, Tredan, Olivier, Filleron, Thomas, Frenel, Jean-Sébastien, and Delaloge, Suzette

Published
2022
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24. Overall survival with neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): A randomised, double-blind, placebo-controlled, phase 3 trial

Author

Holmes, Frankie A., Moy, Beverly, Delaloge, Suzette, Chia, Stephen K.L., Ejlertsen, Bent, Mansi, Janine, Iwata, Hiroji, Gnant, Michael, Buyse, Marc, Barrios, Carlos H., Silovski, Tajana, Šeparović, Robert, Bashford, Anna, Zotano, Angel Guerrero, Denduluri, Neelima, Patt, Debra, Gokmen, Erhan, Gore, Ira, Smith, John W., II, Loibl, Sibylle, Masuda, Norikazu, Tomašević, Zorica, Petráková, Katarina, DiPrimeo, Daniel, Wong, Alvin, Martin, Miguel, and Chan, Arlene

Published
2023
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25. Anthracycline-containing and taxane-containing chemotherapy for early-stage operable breast cancer: a patient-level meta-analysis of 100 000 women from 86 randomised trials

Author

Braybrooke, Jeremy, Bradley, Rosie, Gray, Richard, Hills, Robert K, Pan, Hongchao, Peto, Richard, Dodwell, David, McGale, Paul, Taylor, Carolyn, Aihara, Tomohiko, Anderson, Stewart, Blum, Joanne, Cardoso, Fatima, Chen, Xiaosong, Crown, John P, Ejlertsen, Bent, Friedl, Thomas W P, Harbeck, Nadia, Janni, Wolfgang, Jensen, Maj-Britt, Mamounas, Eleftherios, Narui, Kazutaka, Nitz, Ulrike, Norton, Larry, O'Shaughnessy, Joyce, Piccart, Martine, Robert, Nicholas, Shao, Zhi-Ming, Slamon, Dennis, Sparano, Joseph, Watanabe, Toru, Yothers, Greg, Yu, Ke-Da, Berry, Richard, Boddington, Clare, Clarke, Mike, Davies, Christina, Davies, Lucy, Duane, Fran, Evans, Vaughan, Gay, Jo, Gettins, Lucy, Godwin, Jon, James, Sam, Lui, Hui, Lui, Zulian, MacKinnon, Elizabeth, Mannu, Gurdeep, McHugh, Theresa, Morris, Philip, Read, Simon, Straiton, Ewan, Buzdar, Aman, Suman, Vera J, Hunt, Kelly K, Leonard, Robert C F, Mansi, Janine, Delbaldo, Catherine, Piedbois, Pascal, Quinaux, Emmanuel, Fesl, Christian, Gnant, Michael, Sölkner, Lidija, Steger, Guenther, Eikesdal, Hans Petter, Lønning, Per Eystein, Bee, Valerie, Fung, Helena, Mackey, John, Martin, Miguel, Press, Michael, De Azambuja, Evandro, Gelber, Richard, Regan, Meredith, Di Leo, Angelo, Van Dooren, Veerle, Nogaret, Jean Marie, Bartlett, John, Chen, Bingshu E, Gelmon, Karen, Goss, Paul E, Levine, Mark N, Parulekar, Wendy, Pritchard, Kathleen I, Shepherd, Lois, Berry, Donald, Cirrincione, Constance, Shulman, Lawrence N, Winer, Eric, Gelman, Rebecca S, Harris, Jay R, Henderson, Craig, Shapiro, Charles L, Christiansen, Peer, Ewertz, Marianne, Mouridsen, Henning T, Van Leeuwen, Elise, Linn, Sabine, Van Rossum, Annelot G J, Van Tinteren, Harm, Van Werkhoven, Erik, Goldstein, Lori, Gray, Robert, Eiermann, Wolfgang, Gianni, Luca, Valagussa, Pinuccia, Bogaerts, Jan, Bonnefoi, Herve, Poncet, Coralie, Huovinen, Riikka, Joensuu, Heikki, Bonneterre, Jacques, Fargeot, Pierre, Fumoleau, Pierre, Kerbrat, Pierre, Luporsi, Elisabeth, Namer, Moïse, Carrasco, Eva M, Segui, Miguel Angel, Meisner, Christoph, Loibl, Sibylle, Nekljudova, Valentina, Thomssen, Christoph, Von Minckwitz, Gunter, Kümmel, Sherko, Lopez, Massimo, Vici, Patrizia, Fountzilas, George, Koliou, Georgia, Mavroudis, Dimitrios, Saloustros, Emmanouil, Brain, Etienne, Delaloge, Suzette, Michiels, Stefan, Mathoulin-Pelissier, Simone, Bines, Jose, Sarmento, Roberta M B, Bonadonna, Gianni, Brambilla, Cristina, Rossi, Anna, Bliss, Judith, Coombes, Raoul Charles, Kilburn, Lucy, Marty, Michel, Amadori, Dino, Boccardo, Francesco, Nanni, Oriana, Rubagotti, Alessandra, Scarpi, Emanuela, Masuda, Norikazu, Toi, Masakazu, Ueno, Takayuki, Ishikawa, Takashi, Matsumoto, Koji, Takao, Shintaro, Sommer, Harald, Foroglou, Pericles, Giokas, George, Kondylis, D, Lissaios, Byron, Reinisch, Mattea, Lee, Keun Seok, Nam, Byung-Ho, Ro, Jung Sil, De Matteis, Andrea, Perrone, Francesco, Tang, Gong, Wolmark, Norman, Hozumi, Yasuo, Nomura, Yasuo, Earl, Helena, Hiller, Louise, Vallier, Anne-Laure, De Mastro, Lucia, Venturini, Macro, Delozier, Thierry, Lemonnier, Jerome, Martin, Anne-Laure, Roché, Henri, Spielmann, Marc, Chen, Xiasong, Shen, Kunwei, Albain, Kathy, Barlow, William, Budd, George T, Gralow, Julie, Hayes, Dan, Bartlett-Lee, Peter, Ellis, Paul, Bianco, Angelo Raffaele, De Laurentiis, Michelino, De Placido, Sabino, Wildiers, Hans, Hsu, Limin, Eremin, Oleg, Walker, Leslie G, Ahlgren, Johan, Blomqvist, Carl, Holmberg, Lars, Lindman, Henrik, Asmar, Lina, Jones, Stephen E, Gluz, Oleg, Liedtke, Cornelia, Arriagada, Rodrigo, Bergsten-Nordström, Elizabeth, Carey, Lisa, Coleman, Robert, Cuzick, Jack, Davidson, Nancy, Dignam, James, Dowsett, Mitch, Francis, Prudence A, Goetz, Matthew P, Goodwin, Pam, Halpin-Murphy, Pat, Hill, Catherine, Jagsi, Reshma, Mukai, Hirofumi, Ohashi, Yasuo, Pierce, Lori, Poortmans, Philip, Raina, Vinod, Rea, Daniel, Robertson, John, Rutgers, Emiel, Salgado, Roberto, Spanic, Tanja, Tutt, Andrew, Viale, Giuseppe, Wang, Xiang, Whelan, Tim, Wilcken, Nicholas, Cameron, David, Bergh, Jonas, and Swain, Sandra M

Published
2023
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26. Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in HER2-Positive Metastatic Breast Cancer Previously Treated With ≥ 2 HER2-Directed Regimens: Phase III NALA Trial

Author

Saura, Cristina, Oliveira, Mafalda, Feng, Yin-Hsun, Dai, Ming-Shen, Chen, Shang-Wen, Hurvitz, Sara A, Kim, Sung-Bae, Moy, Beverly, Delaloge, Suzette, Gradishar, William, Masuda, Norikazu, Palacova, Marketa, Trudeau, Maureen E, Mattson, Johanna, Yap, Yoon Sim, Hou, Ming-Feng, De Laurentiis, Michelino, Yeh, Yu-Min, Chang, Hong-Tai, Yau, Thomas, Wildiers, Hans, Haley, Barbara, Fagnani, Daniele, Lu, Yen-Shen, Crown, John, Lin, Johnson, Takahashi, Masato, Takano, Toshimi, Yamaguchi, Miki, Fujii, Takaaki, Yao, Bin, Bebchuk, Judith, Keyvanjah, Kiana, Bryce, Richard, and Brufsky, Adam

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Breast Cancer, Prevention, Clinical Research, Cancer, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Aged, Antineoplastic Combined Chemotherapy Protocols, Brain Neoplasms, Breast Neoplasms, Breast Neoplasms, Male, Capecitabine, Diarrhea, Female, Humans, Kaplan-Meier Estimate, Lapatinib, Male, Middle Aged, Nausea, Progression-Free Survival, Quality of Life, Quinolines, Receptor, ErbB-2, Retreatment, Survival Rate, NALA Investigators, Receptor, erbB-2, Clinical Sciences, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

PurposeNALA (ClinicalTrials.gov identifier: NCT01808573) is a randomized, active-controlled, phase III trial comparing neratinib, an irreversible pan-HER tyrosine kinase inhibitor (TKI), plus capecitabine (N+C) against lapatinib, a reversible dual TKI, plus capecitabine (L+C) in patients with centrally confirmed HER2-positive, metastatic breast cancer (MBC) with ≥ 2 previous HER2-directed MBC regimens.MethodsPatients, including those with stable, asymptomatic CNS disease, were randomly assigned 1:1 to neratinib (240 mg once every day) plus capecitabine (750 mg/m2 twice a day 14 d/21 d) with loperamide prophylaxis, or to lapatinib (1,250 mg once every day) plus capecitabine (1,000 mg/m2 twice a day 14 d/21 d). Coprimary end points were centrally confirmed progression-free survival (PFS) and overall survival (OS). NALA was considered positive if either primary end point was met (α split between end points). Secondary end points were time to CNS disease intervention, investigator-assessed PFS, objective response rate (ORR), duration of response (DoR), clinical benefit rate, safety, and health-related quality of life (HRQoL).ResultsA total of 621 patients from 28 countries were randomly assigned (N+C, n = 307; L+C, n = 314). Centrally reviewed PFS was improved with N+C (hazard ratio [HR], 0.76; 95% CI, 0.63 to 0.93; stratified log-rank P = .0059). The OS HR was 0.88 (95% CI, 0.72 to 1.07; P = .2098). Fewer interventions for CNS disease occurred with N+C versus L+C (cumulative incidence, 22.8% v 29.2%; P = .043). ORRs were N+C 32.8% (95% CI, 27.1 to 38.9) and L+C 26.7% (95% CI, 21.5 to 32.4; P = .1201); median DoR was 8.5 versus 5.6 months, respectively (HR, 0.50; 95% CI, 0.33 to 0.74; P = .0004). The most common all-grade adverse events were diarrhea (N+C 83% v L+C 66%) and nausea (53% v 42%). Discontinuation rates and HRQoL were similar between groups.ConclusionN+C significantly improved PFS and time to intervention for CNS disease versus L+C. No new N+C safety signals were observed.

Published
2020

27. Standard Anthracycline Based Versus Docetaxel-Capecitabine in Early High Clinical and/or Genomic Risk Breast Cancer in the EORTC 10041/BIG 3-04 MINDACT Phase III Trial.

Author

Delaloge, Suzette, Piccart, Martine, Rutgers, Emiel, Litière, Saskia, van 't Veer, Laura J, van den Berkmortel, Franchette, Brain, Etienne, Dudek-Peric, Aleksandra, Gil-Gil, Miguel, Gomez, Patricia, Hilbers, Florentine S, Khalil, Zaman, Knox, Susan, Kuemmel, Sherko, Kunz, Georg, Lesur, Anne, Pierga, Jean-Yves, Ravdin, Peter, Rubio, Isabel T, Saghatchian, Mahasti, Smilde, Tineke J, Thompson, Alastair M, Viale, Giuseppe, Zoppoli, Gabriele, Vuylsteke, Peter, Tryfonidis, Konstantinos, Poncet, Coralie, Bogaerts, Jan, and Cardoso, Fatima

Subjects
Genetics, Rare Diseases, Breast Cancer, Clinical Trials and Supportive Activities, Human Genome, Cancer, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Aged, Aged, 80 and over, Anthracyclines, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Capecitabine, Docetaxel, Female, Humans, Middle Aged, Prospective Studies, MINDACT investigators and the TRANSBIG Consortium, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeMINDACT demonstrated that 46% of patients with early breast cancer at high clinical but low genomic risk on the basis of MammaPrint may safely avoid adjuvant chemotherapy. A second random assignment (R-C) compared docetaxel-capecitabine with an anthracycline-based regimen.Patients and methodsR-C randomly assigned patients 1:1 between standard anthracycline-based regimens, with or without taxanes (control) and experimental docetaxel 75 mg/m2 intravenously plus oral capecitabine 825 mg/m2 two times per day for 14 days (DC) every 3 weeks for 6 cycles. The primary end point was disease-free survival (DFS). Secondary end points included overall survival and safety.ResultsOf 2,832 patients, 1,301 (45%) were randomly assigned, and 97% complied with R-C assignment. In the control arm, 29.6% only received taxanes (0.5% of N0 patients). DFS events (n = 148) were much less than required (n = 422) as a result of a lower-than-expected accrual and event rate. At 5 years of median follow-up, DFS was not different between DC (n = 652) and control (n = 649; 90.7% [95% CI, 88% to 92.8%] v 88.8% [95% CI, 85.9% to 91.1%]; hazard ratio [HR], 0.83 [95% CI, 0.60 to 1.15]; P = .26). Overall survival (HR, 0.91 [95% CI, 0.54 to 1.53]) and DFS in the clinical high and genomic high-risk subgroup (86.1% v 88.1%; HR, 0.83 [95% CI, 0.58 to 1.21]) were similar in both arms. DC led to more grade 1 neuropathy (27.1% v 11.2%) and more grade 2 hand/foot syndrome (28.5% v 3.3%) and diarrhea (13.7% v 5.8%). Serious cardiac events occurred in 9 patients (control, n = 4; DC, n = 5). Fifty-three patients developed second cancers (control, n = 32; DC, n = 21; leukemia: 2 v 1). Five treatment-related deaths occurred (control, 2 [0.3%]; DC, 3 [0.5%]).ConclusionAlthough underpowered, this second randomization in MINDACT did not show any improvement in outcome or safety with the use of DC compared with anthracycline-based chemotherapy.

Published
2020

29. Facing points of view: Representations on adjuvant endocrine therapy of premenopausal patients after breast cancer and their healthcare providers in France. The FOR-AD study

Author

Roche, Nicolas, Le Provost, Jean-Bernard, Borinelli-Franzoi, Maria-Alice, Boinon, Diane, Martin, Elise, Menvielle, Gwenn, Dumas, Agnès, Rivera, Sofia, Conversano, Angelica, Matias, Margarida, Viansone, Alessandro, Di Meglio, Antonio, Delaloge, Suzette, Vaz-Duarte-Luis, Ines-Maria, Pistilli, Barbara, and Fasse, Léonor

Published
2023
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30. Locoregional Breast Cancer Recurrence in the European Organisation for Research and Treatment of Cancer 10041/BIG 03-04 MINDACT Trial: Analysis of Risk Factors Including the 70-Gene Signature

Author

Alaeikhanehshir, Sena, primary, Ajayi, Taiwo, additional, Duijnhoven, Frederieke H., additional, Poncet, Coralie, additional, Olaniran, Ridwan O., additional, Lips, Esther H., additional, van 't Veer, Laura J., additional, Delaloge, Suzette, additional, Rubio, Isabel T., additional, Thompson, Alastair M., additional, Cardoso, Fatima, additional, Piccart, Martine, additional, and Rutgers, Emiel J.T., additional

Published
2024
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31. Digital remote monitoring plus usual care versus usual care in patients treated with oral anticancer agents: the randomized phase 3 CAPRI trial

Author

Mir, Olivier, Ferrua, Marie, Fourcade, Aude, Mathivon, Delphine, Duflot-Boukobza, Adeline, Dumont, Sarah, Baudin, Eric, Delaloge, Suzette, Malka, David, Albiges, Laurence, Pautier, Patricia, Robert, Caroline, Planchard, David, de Botton, Stéphane, Scotté, Florian, Lemare, François, Abbas, May, Guillet, Marilène, Puglisi, Vanessa, Di Palma, Mario, and Minvielle, Etienne

Published
2022
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32. Switch to fulvestrant and palbociclib versus no switch in advanced breast cancer with rising ESR1 mutation during aromatase inhibitor and palbociclib therapy (PADA-1): a randomised, open-label, multicentre, phase 3 trial

Author

BIDARD, Francois-Clement, PISTILLI, Barbara, DALENC, Florence, BACHELOT, Thomas, DE LA MOTTE ROUGE, Thibault, SABATIER, Renaud, DUBOT, Coraline, FRENEL, Jean-Sébastien, FERRERO, Jean-Marc, LADOIRE, Sylvain, LEVY, Christelle, MOURET-REYNIER, Marie-Ange, HARDY-BESSARD, Anne-Claire, LORTHOLARY, Alain, GRENIER, Julien, CHAKIBA, Camille, STEFANI, Laetitia, SOULIE, Patrick, JACQUIN, Jean-Philippe, PLAZA, Jérôme Edouard, CLATOT, Florian, TEIXEIRA, Luis, D'HONDT, Véronique, VEGAS, Hélène, DERBEL, Olfa, GARNIER TIXIDRE, Claire, DELBALDO, Catherine, MOREAU, Lionel, CHENEAU, Caroline, PAITEL, Jean-François, BERNARD-MARTY, Chantal, SPAETH, Dominique, GENET, Dominique, MOULLET, Isabelle, BONICHON-LAMICHHANE, Nathalie, DEIANA, Laura, GREILSAMER, Charlotte, VENAT-BOUVET, Laurence, DELECROIX, Valérie, MELIS, Adrien, ORFEUVRE, Hubert, NGUYEN, Suzanne, LEGOUFFE, Eric, ZANNETTI, Alain, LE SCODAN, Romuald, DOHOLLOU, Nadine, DALIVOUST, Philippe, ARSENE, Olivier, MARQUES, Nathalie, PETIT, Thierry, MOLLON, Delphine, DAUBA, Jérôme, BONNIN, Nathalie, MORVAN, François, GARDNER, Miriam, MARTI, Adina, LEVACHE, Charles-Briac, LACHAIER, Emma, ACHILLE, Mihaela, VALMAR, Christophe, BOUAITA, Ryan, MEDIONI, Jacques, FOA, Cyril, DEL PIANO, Francesco, GOZY, Michel, ESCANDE, Anne, LEDUC, Nicolas, LUCAS, Brigitte, MILLE, Dominique, AMMARGUELLAT, Hanifa, NAJEM, Abeer, TROUBOUL, Fanny, BARTHELEMY, Philippe, DESCLOS, Hervé, MAYEUR, Didier, LORCHEL, Fabrice, GUINET, François, LAURENTY, Anne-Pascale, BOUDRANT, Axelle, GISSEROT, Olivier, ALLEAUME, Corinne, DE GRAMONT, Aimery, Bidard, François-Clément, Hardy-Bessard, Anne-Claire, Dalenc, Florence, Bachelot, Thomas, Pierga, Jean-Yves, de la Motte Rouge, Thibault, Sabatier, Renaud, Dubot, Coraline, Frenel, Jean-Sébastien, Ferrero, Jean Marc, Ladoire, Sylvain, Levy, Christelle, Mouret-Reynier, Marie-Ange, Lortholary, Alain, Grenier, Julien, Chakiba, Camille, Stefani, Laetitia, Plaza, Jérôme Edouard, Clatot, Florian, Teixeira, Luis, D'Hondt, Véronique, Vegas, Hélène, Derbel, Olfa, Garnier-Tixidre, Claire, Canon, Jean-Luc, Pistilli, Barbara, André, Fabrice, Arnould, Laurent, Pradines, Anne, Bièche, Ivan, Callens, Céline, Lemonnier, Jérôme, Berger, Frédérique, and Delaloge, Suzette

Published
2022
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33. A response to "Personalised medicine and population health: breast and ovarian cancer".

Author

Antoniou, Antonis, Anton-Culver, Hoda, Borowsky, Alexander, Broeders, Mireille, Brooks, Jennifer, Chiarelli, Anna, Chiquette, Jocelyne, Cuzick, Jack, Delaloge, Suzette, Devilee, Peter, Dorval, Michael, Easton, Douglas, Eisen, Andrea, Eklund, Martin, Eloy, Laurence, Esserman, Laura, Garcia-Closas, Montserrat, Goldgar, David, Hall, Per, Knoppers, Bartha Maria, Kraft, Peter, La Croix, Andrea, Madalensky, Lisa, Mavaddat, Nasim, Mittman, Nicole, Nabi, Hermann, Olopade, Olufunmilayo, Pashayan, Nora, Schmidt, Marjanka, Shieh, Yiwey, Simard, Jacques, Stover-Fiscallini, Allison, Tice, Jeffrey A, Van't Veer, Laura, Wenger, Neil, Wolfson, Michael, Yau, Christina, and Ziv, Elad

Subjects
Humans, Breast Neoplasms, Ovarian Neoplasms, Health Care Costs, Female, Early Detection of Cancer, Precision Medicine, Population Health, Genetics & Heredity, Genetics, Complementary and Alternative Medicine, Paediatrics and Reproductive Medicine
Published
2019

37. Study protocol comparing the ethical, psychological and socio-economic impact of personalised breast cancer screening to that of standard screening in the “My Personal Breast Screening” (MyPeBS) randomised clinical trial

Author

Roux, Alexandra, Cholerton, Rachel, Sicsic, Jonathan, Moumjid, Nora, French, David P., Giorgi Rossi, Paolo, Balleyguier, Corinne, Guindy, Michal, Gilbert, Fiona J., Burrion, Jean-Benoit, Castells, Xavier, Ritchie, David, Keatley, Debbie, Baron, Camille, Delaloge, Suzette, and de Montgolfier, Sandrine

Published
2022
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38. Randomized Phase III Study of Amcenestrant Plus Palbociclib Versus Letrozole Plus Palbociclib in Estrogen Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer: Primary Results From AMEERA-5.

Author

Cortés, Javier, Hurvitz, Sara A., O'Shaughnessy, Joyce, Delaloge, Suzette, Iwata, Hiroji, Rugo, Hope S., Neven, Patrick, Kanagavel, Dheepak, Cohen, Patrick, Paux, Gautier, Cartot-Cotton, Sylvaine, Stefanova-Urena, Maya, Deyme, Laure, Aouni, Jihane, Sebastien, Bernard, and Bardia, Aditya

Published
2024
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39. Multicenter evaluation of breast cancer patients’ satisfaction and experience with oncology telemedicine visits during the COVID-19 pandemic

Author

Bizot, Alexandra, Karimi, Maryam, Rassy, Elie, Heudel, Pierre Etienne, Levy, Christelle, Vanlemmens, Laurence, Uzan, Catherine, Deluche, Elise, Genet, Dominique, Saghatchian, Mahasti, Giacchetti, Sylvie, Grenier, Juline, Patsouris, Anne, Dieras, Véronique, Pierga, Jean-Yves, Petit, Thierry, Ladoire, Sylvain, Jacot, William, Benderra, Marc-Antoine, De Jesus, Anne, Delaloge, Suzette, Lambertini, Matteo, and Pistilli, Barbara

Published
2021
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41. Customizing local and systemic therapies for women with early breast cancer: the St. Gallen International Consensus Guidelines for treatment of early breast cancer 2021

Author

Aebi, Stephan, André, Fabrice, Barrios, Carlos, Bergh, Jonas, Bonnefoi, Herve, Bretel Morales, Denisse, Brucker, Sara, Burstein, Harold, Cameron, David, Cardoso, Fatima, Carey, Lisa, Chua, Boon, Ciruelos, Eva, Colleoni, Marco, Curigliano, Giuseppe, Delaloge, Suzette, Denkert, Carsten, Dubsky, Peter, Ejlertsen, Bent, Fitzal, Florian, Francis, Prudence, Galimberti, Viviana, Gamal El Din Mohamed Mahmoud, Hebatallah, Garber, Judy, Gnant, Michael, Gradishar, William, Gulluoglu, Bahadir, Harbeck, Nadia, Huang, Chiun-Sheng, Huober, Jens, Ilbawi, Andre, Jiang, Zefei, Johnston, Steven, Lee, Eun Sook, Loibl, Sibylle, Morrow, Monica, Partridge, Ann, Piccart, Martine, Poortmans, Philip, Prat, Aleix, Regan, Meredith, Rubio, Isabella, Rugo, Hope, Rutgers, Emiel, Sedlmayer, Felix, Semiglazov, Vladimir, Senn, Hans-Joerg, Shao, Zhiming, Spanic, Tanja, Tesarova, Petra, Thürlimann, Beat, Tjulandin, Sergei, Toi, Masakazu, Trudeau, Maureen, Turner, Nicholas, Vaz Luis, Inez, Viale, Giuseppe, Watanabe, Toru, Weber, Walter P., Winer, Eric P., Xu, Binghe, Burstein, H.J., Curigliano, G., Thürlimann, B., Weber, W.P., Poortmans, P., Regan, M.M., Senn, H.J., Winer, E.P., and Gnant, M.

Published
2021
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42. Trastuzumab for early-stage, HER2-positive breast cancer: a meta-analysis of 13 864 women in seven randomised trials

Author

Bradley, Rosie, Braybrooke, Jeremy, Gray, Richard, Hills, Robert, Liu, Zulian, Peto, Richard, Davies, Lucy, Dodwell, David, McGale, Paul, Pan, Hongchao, Taylor, Carolyn, Anderson, Stewart, Gelber, Richard, Gianni, Luca, Jacot, William, Joensuu, Heikki, Moreno-Aspitia, Alvaro, Piccart, Martine, Press, Michael, Romond, Edward, Slamon, Dennis, Suman, Vera, Berry, Richard, Boddington, Clare, Clarke, Mike, Davies, Christina, Duane, Fran, Evans, Vaughan, Gay, Jo, Gettins, Lucy, Godwin, Jon, James, Sam, Liu, Hui, MacKinnon, Elizabeth, Mannu, Gurdeep, McHugh, Theresa, Morris, Philip, Read, Simon, Straiton, Ewan, Wang, Yaochen, Crown, John, de Azambuja, Evandro, Delaloge, Suzette, Fung, Helena, Geyer, Charles, Spielmann, Marc, Valagussa, Pinuccia, Albain, Kathy, Arriagada, Rodrigo, Bartlett, John, Bergsten-Nordström, Elizabeth, Bliss, Judith, Brain, Etienne, Carey, Lisa, Coleman, Robert, Cuzick, Jack, Davidson, Nancy, Del Mastro, Lucia, Di Leo, Angelo, Dignam, James, Dowsett, Mitch, Ejlertsen, Bent, Francis, Prue, Gnant, Michael, Goetz, Matthew, Goodwin, Pam, Halpin-Murphy, Pat, Hayes, Dan, Hill, Catherine, Jagsi, Reshma, Janni, Wolfgang, Loibl, Sibylle, Mamounas, Eleftherios P, Martín, Miguel, Mukai, Hirofumi, Nekljudova, Valentina, Norton, Larry, Ohashi, Yasuo, Pierce, Lori, Poortmans, Philip, Raina, Vinod, Rea, Daniel, Regan, Meredith, Robertson, John, Rutgers, Emiel, Spanic, Tanja, Sparano, Joseph, Steger, Guenther, Tang, Gong, Toi, Masakazu, Tutt, Andrew, Viale, Giuseppe, Wang, Xiang, Whelan, Tim, Wilcken, Nicholas, Wolmark, Norman, Cameron, David, Bergh, Jonas, Pritchard, Kathleen I, and Swain, Sandra M

Published
2021
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43. Intestinal microbiota influences clinical outcome and side effects of early breast cancer treatment

Author

Terrisse, Safae, Derosa, Lisa, Iebba, Valerio, Ghiringhelli, François, Vaz-Luis, Ines, Kroemer, Guido, Fidelle, Marine, Christodoulidis, Stergios, Segata, Nicola, Thomas, Andrew Maltez, Martin, Anne-Laure, Sirven, Aude, Everhard, Sibille, Aprahamian, Fanny, Nirmalathasan, Nitharsshini, Aarnoutse, Romy, Smidt, Marjolein, Ziemons, Janine, Caldas, Carlos, Loibl, Sibylle, Denkert, Carsten, Durand, Sylvere, Iglesias, Claudia, Pietrantonio, Filippo, Routy, Bertrand, André, Fabrice, Pasolli, Edoardo, Delaloge, Suzette, and Zitvogel, Laurence

Published
2021
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45. 70-gene signature as an aid for treatment decisions in early breast cancer: updated results of the phase 3 randomised MINDACT trial with an exploratory analysis by age

Author

Piccart, Martine, van 't Veer, Laura J, Poncet, Coralie, Lopes Cardozo, Josephine M N, Delaloge, Suzette, Pierga, Jean-Yves, Vuylsteke, Peter, Brain, Etienne, Vrijaldenhoven, Suzan, Neijenhuis, Peter A, Causeret, Sylvian, Smilde, Tineke J, Viale, Giuseppe, Glas, Annuska M, Delorenzi, Mauro, Sotiriou, Christos, Rubio, Isabel T, Kümmel, Sherko, Zoppoli, Gabriele, Thompson, Alastair M, Matos, Erika, Zaman, Khalil, Hilbers, Florentine, Fumagalli, Debora, Ravdin, Peter, Knox, Susan, Tryfonidis, Konstantinos, Peric, Aleksandra, Meulemans, Bart, Bogaerts, Jan, Cardoso, Fatima, and Rutgers, Emiel J T

Published
2021
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46. Recommandations francophones pour la pratique clinique concernant la prise en charge des cancers du sein de Saint-Paul-de-Vence 2022-2023

Author

Aapro, Matti, Al-Ghazali, Hesham, Bachelot, Thomas, Barranger, Emmanuel, Berrada, Narjiss, Bidard, François-Clément, Bounedjar, Adda, Boussen, Hamouda, Campone, Mario, Cardoso, Fatima, Ceugnart, Luc, Classe, Jean-Marc, Cohen, Monique, Coutant, Charles, Cutuli, Bruno, Dalenc, Florence, Dieras, Véronique, Dohollou, Nadine, Giacchetti, Sylvie, Goncalves, Anthony, Freyer, Gilles, Hannoun-Levi, Jean-Michel, Hardy-Bessard, Anne-Claire, Jacquin, Jean-Philippe, Jacot, William, Kerrou, Khaldoun, Ladoire, Sylvain, Lerebours, Florence, Levy, Christelle, Llombart-Cussac, Antonio, Loirat, Delphine, Thomassin, Isabelle, Piccart, Martine, Petit, Thierry, Radosevic-Robin, Nina, Rotenberg, Luc, Rouzier, Roman, Salmon, Rémy, Vincent-Salomon, Anne, Spano, Jean-Philippe, Tallet, Agnès, Teixera, Luis, Tredan, Olivier, Verret, Benjamin, Zarca, Daniel, Zelek, Laurent, Zerbib, Eric, Gligorov, Joseph, Benderra, Marc-Antoine, Barthere, Xavier, de Forceville, Louise, Antoine, Eric Charles, Cottu, Paul Henri, Delaloge, Suzette, Pierga, Jean-Yves, Belkacemi, Yazid, Houvenaegel, Gilles, Pujol, Pascal, Rivera, Sofia, Spielmann, Marc, Penault-Llorca, Frédérique, and Namer, Moise

Published
2023
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47. Impact of body mass index on overall survival in patients with metastatic breast cancer

Author

Saleh, Khalil, Carton, Matthieu, Dieras, Véronique, Heudel, Pierre-Etienne, Brain, Etienne, D’Hondt, Véronique, Mailliez, Audrey, Patsouris, Anne, Mouret-Reynier, Marie-Ange, Goncalves, Anthony, Ferrero, Jean Marc, Petit, Thierry, Emile, George, Uwer, Lionel, Debled, Marc, Dalenc, Florence, Jouannaud, Christelle, Ladoire, Sylvain, Leheurteur, Marianne, Cottu, Paul, Veron, Lucie, Savignoni, Alexia, Courtinard, Coralie, Robain, Mathieu, Delaloge, Suzette, and Deluche, Elise

Published
2021
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48. Prospective Multicenter Study Validate a Prediction Model for Surgery Uptake Among Women with Atypical Breast Lesions

Author

Uzan, Catherine, Mazouni, Chafika, Rossoni, Caroline, De Korvin, Brigitte, de Lara, Christine Tunon, Cohen, Monique, Chabbert, Nathalie, Zilberman, Sonia, Boussion, Veronique, Vincent Salomon, Anne, Espie, Marc, Coutant, Charles, Marchal, Frederic, Salviat, Flore, Boulanger, Loic, Doutriaux-Dumoulin, Isabelle, Jouve, Eva, Mathelin, Carole, de Saint hilaire, Pierre, Mollard, Joelle, Balleyguier, Corinne, Joyon, Natacha, Triki, Magali Lacroix, Delaloge, Suzette, and Michiels, Stefan

Published
2021
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49. Patient-Reported Outcomes in OlympiA: A Phase III, Randomized, Placebo-Controlled Trial of Adjuvant Olaparib in g BRCA1/2 Mutations and High-Risk Human Epidermal Growth Factor Receptor 2–Negative Early Breast Cancer.

Author

Ganz, Patricia A., Bandos, Hanna, Španić, Tanja, Friedman, Sue, Müller, Volkmar, Kuemmel, Sherko, Delaloge, Suzette, Brain, Etienne, Toi, Masakazu, Yamauchi, Hideko, de Dueñas, Eduardo-M., Armstrong, Anne, Im, Seock-Ah, Song, Chuan-gui, Zheng, Hong, Sarosiek, Tomasz, Sharma, Priyanka, Geng, Cuizhi, Fu, Peifen, and Rhiem, Kerstin

Published
2024
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