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Although randomized controlled clinical trials are optimal to evaluate the effect of an experimental therapy, single-arm trials are required whenever randomization is unethical or not feasible, such as de-escalation studies. We propose using prospectively identified historical controls to place results of single-arm, de-escalation trials into context. POSITIVE is a prospective, single-arm study in young women with hormone-receptor-positive early breast cancer to determine if temporarily interrupting adjuvant endocrine therapy in order to become pregnant increases the risk of a breast cancer event. After 272 women enrolled in POSITIVE, we identified a cohort of 1499 SOFT/TEXT patients potentially eligible to enroll in POSITIVE who did not interrupt endocrine therapy. Method I used the SOFT/TEXT cohort to calculate annualized hazard rates by a piecewise exponential model. Method II used the SOFT/TEXT cohort to group-match SOFT/TEXT patients to POSITIVE patients; sample sets of SOFT/TEXT patients were randomly drawn 5000 times to obtain sets having patient, disease, and treatment characteristics more balanced with POSITIVE participants. Compared with SOFT/TEXT, POSITIVE participants were younger, less likely to be overweight/obese, had fewer positive nodes, and fewer received aromatase inhibitor or chemotherapy. The estimated 3-year breast cancer free interval event rates were 9.5% (95% CI: 7.9%,11.1%) for Method I and 9.4% (95% CI: 7.8%,10.9%) for Method II, compared with 5.8% initially assumed when POSITIVE was designed. External control datasets should be identified before launching single-arm, de-escalation trials and methods applied during their conduct to provide context for interim monitoring and interpretation of the final analysis. • Prospective identification of external historical controls for single-arm studies. • Statistical methods for estimating historical control rates for single-arm studies. • Methods applied for interim monitoring and final analysis of the POSITIVE study. [ABSTRACT FROM AUTHOR]

The 2nd International Consensus Conference for Breast Cancer in Young Women (BCY2) took place in November 2014, in Dublin, Ireland organized by the European School of Oncology (ESO). Consensus recommendations for the management of breast cancer in young women (BCYW) were updated from BCY1 with incorporation of new evidence to inform the guidelines, and areas of research priorities were identified. This manuscript summarizes these international consensus recommendations, which are also endorsed by the European Society of Breast Specialists (EUSOMA). [ABSTRACT FROM AUTHOR]

Managing estrogen receptor-positive breast cancer in young women (<40 years) requires a multidisciplinary/personalized approach, covering both clinical and psychosocial aspects. Five years of tamoxifen has been the standard adjuvant endocrine therapy for many years. Recent data from the adjuvant randomized trials TEXT-SOFT show that the aromatase inhibitor exemestane plus ovarian suppression significantly reduces recurrences as compared with tamoxifen plus ovarian suppression. The ATLAS and aTToM trials represent the first evidence of a beneficial effect of extended endocrine therapy with tamoxifen in premenopausal women. Outside of a clinical trial, no data support neoadjuvant endocrine therapy in young women. In the metastatic setting, tamoxifen or aromatase inhibitors, both with ovarian suppression/ablation, should be the preferred choice, unless rapid tumor shrinkage is needed. No data are available with fulvestrant in young patients. [ABSTRACT FROM AUTHOR]

Managing estrogen receptor-positive breast cancer in young women (<40 years) requires a multidisciplinary/personalized approach, covering both clinical and psychosocial aspects. Five years of tamoxifen has been the standard adjuvant endocrine therapy for many years. Recent data from the adjuvant randomized trials TEXT-SOFT show that the aromatase inhibitor exemestane plus ovarian suppression significantly reduces recurrences as compared with tamoxifen plus ovarian suppression. The ATLAS and aTToM trials represent the first evidence of a beneficial effect of extended endocrine therapy with tamoxifen in premenopausal women. Outside of a clinical trial, no data support neoadjuvant endocrine therapy in young women. In the metastatic setting, tamoxifen or aromatase inhibitors, both with ovarian suppression/ablation, should be the preferred choice, unless rapid tumor shrinkage is needed. No data are available with fulvestrant in young patients. [ABSTRACT FROM AUTHOR]

Abstract: The 1st International Consensus Conference for Breast Cancer in Young Women (BCY1) took place in November 2012, in Dublin, Ireland organized by the European School of Oncology (ESO). Consensus recommendations for management of breast cancer in young women were developed and areas of research priorities were identified. This manuscript summarizes these international consensus recommendations, which are also endorsed by the European Society of Breast Specialists (EUSOMA). [Copyright &y& Elsevier]

Simple Summary: Data on the outcome and treatment of young women with breast cancer (BC) in Switzerland is scarce. We conducted a retrospective cohort study to evaluate treatment and outcome of women aged ≤ 40 years, diagnosed with stage I-III BC in Switzerland between 2000–2014. We found that the majority of patients were treated according to international guidelines, however we identified differences in quality-of-care score across the two Swiss linguistic/geographic regions (Swiss Latin and Swiss German). Survival was high: 91.4% (95% confidence interval (CI) 90.2–92.5) at 5 years and 83.1% (95% CI 81.2–78.5) at 10 years. After adjusting for multiple clinicopathological factors only tumor characteristics and treatment period remained independently associated with survival. We concluded that national guidelines for young women with BC should be implemented to standardize treatment in Switzerland and awareness should be raised among young women and clinicians that BC does not discriminate by age. Background: An increase in breast cancer (BC) incidence in young women (YW) as well as disparities in BC outcomes have been reported in Switzerland. We sought to evaluate treatment and outcome differences among YW with BC (YWBC). Methods: YW diagnosed with stage I-III BC between 2000–2014 were identified through nine cancer registries. Concordance with international guidelines was assessed for 12 items covering clinical/surgical management, combined in a quality-of-care score. We compared score and survival outcome between the two linguistic-geographic regions of Switzerland (Swiss-Latin and Swiss-German) and evaluated the impact of quality-of-care on survival. Results: A total of 2477 women were included. The median age was 37.3 years (IQR 34.0–39.4 years), with 50.3% having stage II BC and 70.3% having estrogen receptor positive tumors. The mean quality-of-care score was higher in the Latin region compared to the German region (86.0% vs. 83.2%, p < 0.0005). Similarly, 5- and 10-year overall survival rates were higher in the Latin compared to the German region (92.3% vs. 90.2%, p = 0.0593, and 84.3% vs. 81.5%, p = 0.0025, respectively). There was no difference in survival according to the score. In the univariate analysis, women in the Latin region had a 28% lower mortality risk compared to women in the German region (hazard ratio 0.72; 95% CI 0.59–0.89). In the multivariable analysis, only stage, differentiation, tumor subtype and treatment period remained independently associated with survival. Conclusions: We identified geographic disparities in the treatment and outcome of YWBC in Switzerland. National guidelines for YWBC should be implemented to standardize treatment. Awareness should be raised among YW and clinicians that BC does not discriminate by age. [ABSTRACT FROM AUTHOR]

Despite breast cancer being uncommon in young women, it is still the most frequent cancer diagnosed in women aged 15–39 years, and the leading cause of death in this age group in high-income countries, after accidents and self-injury. The present review summarizes the most recent guidelines and offers an expert perspective on the many challenges associated with treatment of young women with breast cancer. We will especially focus on early breast cancer, exploring the specificities of the diagnostic process, imaging techniques, locoregional and systemic treatments, and the added value of dedicated multidisciplinary teams. Specific differences in adjuvant treatment between premenopausal and postmenopausal women, especially regarding endocrine therapy, will be addressed in detail. Research questions and current gaps in important fields, such as the paucity of age-specific data regarding antihuman epidermal growth factor receptor 2 (anti-HER2) therapy and gene panels such as OncotypeDX or MAMMAPRINT will be highlighted. A consistent part of this review is dedicated to the issues defining 'young women', such as fertility preservation, managing long-term side effects of oncological treatments and genetic counselling, by detailing current strategies and future perspectives. [ABSTRACT FROM AUTHOR]

Abstract: EUSOMA (The European Society of Breast Cancer Specialists) is committed to writing recommendations on different topics of breast cancer care which can be easily adopted and used by health professionals dedicated to the care of patients with breast cancer in their daily practice. In 2011, EUSOMA identified the management of young women with breast cancer as one of the hot topics for which a consensus among European experts was needed. Therefore, the society recently organised a workshop to define such recommendations. Thirteen experts from the different disciplines met for two days to discuss the topic. This international and multidisciplinary panel thoroughly reviewed the literature in order to prepare evidence-based recommendations. During the meeting, two working groups were set up to discuss in detail diagnosis and loco-regional and systemic treatments, including both group aspects of psychology and sexuality. The conclusions reached by the working groups were then discussed in a plenary session to reach panel consensus. Whenever possible, a measure of the level of evidence (LoE) from 1 (the highest) to 4 (the lowest) degree, based on the methodology proposed by the US Agency for Healthcare Research and Quality (AHRQ), was assigned to each recommendation. The present manuscript presents the recommendations of this consensus group for the management of young women with breast cancer in daily clinical practice. [Copyright &y& Elsevier]