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Purpose: We investigated time to pregnancy, efficacy and safety of fertility preservation, and assisted reproductive technologies (ARTs) in women with early hormone receptor-positive breast cancer (BC) desiring future pregnancy., Patients and Methods: POSITIVE is an international, single-arm, prospective trial, in which 518 women temporarily interrupted adjuvant endocrine therapy to attempt pregnancy. We evaluated menstruation recovery and factors associated with time to pregnancy and investigated if ART use was associated with achieving pregnancy. The cumulative incidence of BC-free interval (BCFI) events was estimated according to the use of ovarian stimulation at diagnosis. The median follow-up was 41 months., Results: Two hundred seventy-three patients (53%) reported amenorrhea at enrollment, of whom 94% resumed menses within 12 months. Among 497 patients evaluable for pregnancy, 368 (74%) reported at least one pregnancy. Young age was the main factor associated with shorter time to pregnancy with cumulative incidences of pregnancy by 1 year of 63.5%, 54.3%, and 37.7% for patients age <35, 35-39, and 40-42 years, respectively. One hundred and seventy-nine patients (36%) had embryo/oocyte cryopreservation at diagnosis, of whom 68 reported embryo transfer after enrollment. Cryopreserved embryo transfer was the only ART associated with higher chance of pregnancy (odds ratio, 2.41 [95% CI, 1.75 to 4.95]). The cumulative incidence of BCFI events at 3 years was similar for women who underwent ovarian stimulation for cryopreservation at diagnosis, 9.7% (95% CI, 6.0 to 15.4), compared with those who did not, 8.7% (95% CI, 6.0 to 12.5)., Conclusion: In POSITIVE, fertility preservation using ovarian stimulation was not associated with short-term detrimental impact on cancer prognosis. Pregnancy rates were highest among those who underwent embryo/oocyte cryopreservation followed by embryo transfer.

Purpose: Many patients and physicians remain concerned about the potential detrimental effects of pregnancy after breast cancer (BC) in terms of reproductive outcomes and maternal safety. This systematic review and meta-analysis aimed at providing updated evidence on these topics., Methods: A systematic literature review was conducted to identify studies including patients with a pregnancy after BC (PROSPERO number CRD42020158324). Likelihood of pregnancy after BC, their reproductive outcomes, and maternal safety were assessed. Pooled relative risks, odds ratios (ORs), and hazard ratios (HRs) with 95% CIs were calculated using random effects models., Results: Of 6,462 identified records, 39 were included involving 8,093,401 women from the general population and 112,840 patients with BC of whom 7,505 had a pregnancy after diagnosis. BC survivors were significantly less likely to have a subsequent pregnancy compared with the general population (relative risk, 0.40; 95% CI, 0.32 to 0.49). Risks of caesarean section (OR, 1.14; 95% CI, 1.04 to 1.25), low birth weight (OR, 1.50; 95% CI, 1.31 to 1.73), preterm birth (OR, 1.45; 95% CI, 1.11 to 1.88), and small for gestational age (OR, 1.16; 95% CI, 1.01 to 1.33) were significantly higher in BC survivors, particularly in those with previous chemotherapy exposure, compared with the general population. No significantly increased risk of congenital abnormalities or other reproductive complications were observed. Compared to patients with BC without subsequent pregnancy, those with a pregnancy had better disease-free survival (HR, 0.66; 95% CI, 0.49 to 0.89) and overall survival (HR, 0.56; 95% CI, 0.45 to 0.68). Similar results were observed after correcting for potential confounders and irrespective of patient, tumor, and treatment characteristics, pregnancy outcome, and timing of pregnancy., Conclusion: These results provide reassuring evidence on the safety of conceiving in BC survivors. Patients' pregnancy desire should be considered a crucial component of their survivorship care plan., Competing Interests: Matteo LambertiniConsulting or Advisory Role: Roche, Novartis, Lilly, AstraZenecaSpeakers' Bureau: Theramex, Takeda, Roche, Lilly, Novartis, Pfizer, Sandoz Richard A. AndersonHonoraria: Merck, IBSAConsulting or Advisory Role: NeRRe Therapeutics, Roche Diagnostics, SojournixResearch Funding: Roche Diagnostics Evandro de AzambujaHonoraria: Roche/Genentech, SeaGen, Zodiac PharmaConsulting or Advisory Role: Roche/Genentech, Novartis, Libbs, Pierre FabreResearch Funding: Roche/Genentech, AstraZeneca, Servier/Pfizer, GlaxoSmithKline/NovartisTravel, Accommodations, Expenses: Roche/Genentech, GlaxoSmithKline Philip D. PoorvuOther Relationship: Medscape Cynthia Villarreal-GarzaConsulting or Advisory Role: Roche, Novartis, Pfizer, LillySpeakers' Bureau: Roche, Myriad Genetics, NovartisResearch Funding: AstraZeneca, RocheTravel, Accommodations, Expenses: Roche, MSD Oncology, Pfizer Barbara PistilliConsulting or Advisory Role: Puma Biotechnology, Pierre Fabre, Novartis, Myriad Genetics, AstraZenecaResearch Funding: Pfizer, Puma Biotechnology, Merus, Daiichi-SankyoTravel, Accommodations, Expenses: Pfizer, AstraZeneca, MSD Oncology, Novartis Ines Vaz-LuisHonoraria: AstraZeneca, Amgen, Pfizer Cristina SauraConsulting or Advisory Role: AstraZeneca, Daiichi Sankyo, Eisai, Exact Sciences, Roche, Exeter Pharmaceuticals, MediTech, Merck Sharp & Dohme, Novartis, Pfizer, Philips, Pierre Fabre, Puma Biotechnology, Sanofi/Aventis, SeaGen, ZymeworksResearch Funding: Genentech, AstraZeneca, Roche, Macrogenics, Novartis, Pfizer, Puma Biotechnology, Synthon, PiqurTravel, Accommodations, Expenses: Pfizer, Novartis, Roche, AstraZeneca, Genomic Health, Puma Biotechnology Kathryn J. RuddyResearch Funding: MedtronicPatents, Royalties, Other Intellectual Property: Spouse and Mayo Clinic have filed patents related to the application of artificial intelligence to the electrocardiogram for diagnosis and risk stratification, and Spouse and Mayo Clinic are involved in a potential equity or royalty relationship with AliveCor Hatem A. Azim JrEmployment: Innate PharmaStock and Other Ownership Interests: Innate PharmaHonoraria: NovartisConsulting or Advisory Role: DiaacurateSpeakers' Bureau: GlaxoSmithKlineTravel, Accommodations, Expenses: Novartis Frederic AmantConsulting or Advisory Role: Clovis Oncology, AstraZeneca, Samsung Bioepis Isabelle DemeestereConsulting or Advisory Role: RocheResearch Funding: Roche DiagnosticTravel, Accommodations, Expenses: Ferring Lucia Del MastroHonoraria: Roche, Novartis, Lilly, MSD OncologyConsulting or Advisory Role: Roche, Novartis, MSD, Pfizer, Ipsen, AstraZeneca, Genomic Health, Lilly, Seattle Genetics, Eisai, Pierre Fabre, Daiichi SankyoTravel, Accommodations, Expenses: Roche, Pfizer, Celgene Ann H. PartridgePatents, Royalties, Other Intellectual Property: I receive small royalty payments for coauthoring the breast cancer survivorship section of UpToDateTravel, Accommodations, Expenses: Novartis Olivia PaganiConsulting or Advisory Role: Pfizer, Roche, Novartis, Takeda, Lilly, Debiopharm Group Fedro A. PeccatoriConsulting or Advisory Role: Roche Molecular Diagnostics, IpsenNo other potential conflicts of interest were reported.

Purpose: We investigated the incidence of cardiac adverse events in patients with early breast cancer in the Herceptin Adjuvant (HERA) trial who were treated with 1 year of trastuzumab after completion of (neo)adjuvant chemotherapy., Patients and Methods: The HERA trial is a three-group, randomized trial that compared 1 year or 2 years of trastuzumab with observation in women with human epidermal growth factor receptor-2 (HER2) -positive early breast cancer. Eligible patients had normal left ventricular ejection fraction (LVEF; >or= 55%) after completion of (neo)adjuvant chemotherapy with or without radiotherapy. Cardiac function was monitored throughout the trial. This analysis considers patients randomly assigned to 1 year of trastuzumab treatment or observation., Results: There were 1,698 patients randomly assigned to observation and 1,703 randomly assigned to 1 year of trastuzumab treatment; 94.1% of patients had been treated with anthracyclines. The incidence of discontinuation of trastuzumab because of cardiac disorders was low (5.1%). At a median follow-up of 3.6 years, the incidence of cardiac end points remained low, though it was higher in the trastuzumab group than in the observation group (severe CHF, 0.8% v 0.0%; confirmed significant LVEF decreases, 3.6% v 0.6%) In the trastuzumab group, 59 of 73 patients with a cardiac end point reached acute recovery; of these 59 patients, 52 were considered by the cardiac advisory board (CAB) to have a favorable outcome from the cardiac end point., Conclusion: The incidence of cardiac end points remains low even after longer-term follow-up. The cumulative incidence of any type of cardiac end point increases during the scheduled treatment period of 1 year, but it remains relatively constant thereafter.

Purpose: Cancer presenting at the medial site of the breast may have a worse prognosis compared with tumors located in external quadrants. For medial tumors, axillary lymph node staging may not accurately reflect the metastatic potential of the disease., Patients and Methods: Eight-thousand four-hundred twenty-two patients randomly assigned to International Breast Cancer Study Group clinical trials between 1978 and 1999 were classified as medial site (1,622; 19%) or lateral, central, and other sites (6,800; 81%). Median follow-up was 11 years., Results: A statistically significant difference was observed for patients with medial tumors versus those with nonmedial tumors in disease-free survival (DFS; 10-year DFS, 46% v 48%; HR, 1.10; 95% CI, 1.02 to 1.18; P = .01) and overall survival (10-year OS 59% v 61%; HR, 1.09; 1.01 to 1.19; P = .04). This difference increased after adjustment for other prognostic factors (HR, 1.22; 95% CI, 1.13 to 1.32 for DFS; and HR, 1.24; 95% CI, 1.14 to 1.35 for OS; both P = .0001). The risk of relapse for patients with medial presentation was largest for the node-negative cohort and for patients with tumors larger than 2 cm. In the subgroup of 2,931 patients with negative axillary lymph nodes, 10-year DFS was 61% v 67%, and OS was 73% v 80% for medial versus nonmedial sites, respectively (HR 1.33; 95% CI, 1.15 to 1.54; P = .0001 for DFS; and HR 1.40; 95% CI, 1.17 to 1.67; P = .0003 for OS)., Conclusion: Tumor site has a significant prognostic utility, especially for axillary lymph node-negative disease, that should be considered in therapeutic algorithms. New staging procedures such as biopsy of the sentinel internal mammary nodes or novel imaging methods should be further studied in patients with medial tumors.