During the past years, clinical routine has shifted away from relying solely on clinicopathologic factors toward increasing use of multigene expression assays in guiding treatment decisions regarding adjuvant chemotherapy (CT) for hormone receptor-positive, HER2-negative early breast cancer (EBC) with 0 to 3 positive lymph nodes. In the case of a low genomic risk, there is a strong consensus in favor of pure endocrine therapy (ET) for postmenopausal patients regardless of the clinical risk (data from the PlanB-, ADAPT-, RxPonder-, TailorX- and MINDACT-studies). However, there is uncertainty regarding the optimal therapy for pre- and perimenopausal patients with a similar clinical/genomic risk profile. Since the observed benefit of CT in this patient group may be partly attributable to CT-induced ovarian function suppression (OFS), some of these patients could be spared CT by adding OFS to endocrine therapy. The West German Study Group (WSG) initiated the PROOFS-registry to create a real-world database and to obtain clarity how to optimally treat these patients.
PROOFS (NCT pending) is an observational, non-interventional registry aiming at the long-term follow up of pre- or perimenopausal patients with luminal EBC with intermediate to high clinical risk for recurrence and low genomic risk measured by MammaPrint®. Study participants will receive standard-of-care treatment at physicians´ discretion and according to clinical routine, which may include CT neoadjuvant or adjuvant + ET, ET + OFS in premenopausal, or ET +/- OFS in perimenopausal women. The registry aims to give insights in the real-world use of OFS and to confirm an excellent outcome in patients treated by ET +/- OFS alone. In addition, quality of life is captured (QLQ BR23 and QLQ-C30). The study is open for recruitment of 1470 patients (approximately 20% receiving CT and 80% receiving ET +/- OFS) at up to 100 centers in Germany.
Westdeutsche Studiengruppe GmbH.
Agendia N.V., Amsterdam.
O. Gluz: Financial Interests, Personal, Advisory Board: Roche, Lilly, Amgen, Novartis, Pierre Fabre, MSD, Celgene, Pfizer, Gilead, Molecular Health, Seagen; Financial Interests, Personal, Invited Speaker: AstraZeneca, Exact Science; Financial Interests, Institutional, Invited Speaker: Roche; Non-Financial Interests, Leadership Role: West German Study Group; Non-Financial Interests, Personal, Proprietary Information: West German Study Group. M. Graeser: Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Other: Daiichi Sankyo, AstraZeneca. U.A. Nitz: Financial Interests, Personal, Advisory Role: Agendia;, Amgen;, Celgene;, Genomic Health, NanoString Technologies, Novartis pharma, fizer Pharmaceuticals;, Roche/Genentech, Teva; Financial Interests, Institutional, Sponsor/Funding: Agendia, Amgen, Celgene, Roche, Sanofi. N. Harbeck: Financial Interests, Personal, Invited Speaker: AstraZeneca, Daiichi Sankyo, Lilly, MSD, Novartis, Pierre Fabre, Roche, Seagen, Medscape, Art Tempi, Onkowissen, Gilead, Sanofi, Exact Sciences; Financial Interests, Personal, Advisory Board: AstraZeneca, Daiichi Sankyo, Novartis, Pfizer, Roche, Sandoz-Hexal, Seagen, Aptitude Health, Gilead, Sanofi; Financial Interests, Personal, Other, Husband: WSG (Husband); Financial Interests, Personal, Ownership Interest: West German Study Group; Financial Interests, Institutional, Funding: AstraZeneca, BMS, Daiichi Sankyo, Lilly, MSD, Novartis, Pierre Fabre, TRIO, Roche, Palleos, Seagen, WSG; Non-Financial Interests, Member, Member German AGO Breast Guideline Committee: AGO Breast Committee; Non-Financial Interests, Member, Breast Cancer Educational Programs: ESO/ESCO; Other, Founding Editor: BreastCare Journal. S. Kuemmel: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Celgene, Daiichi Sankyo, Lilly, MSD, Novartis, Seagen, Pfizer, Roche, Somatex, Gilead, Sanofi; Financial Interests, Personal, Invited Speaker: ExactScience, pfm medical, MSD, Lilly, Gilead, Roche, Sanofi, Daiichi Sankyo; Financial Interests, Personal, Ownership Interest, Minority Ownership: WSG Study Group; Financial Interests, Personal and Institutional, Invited Speaker: Roche, Novartis; Financial Interests, Institutional, Invited Speaker: Roche, Novartis, Lilly, Somatex, AstraZeneca, MSD. R. Wuerstlein: Financial Interests, Personal, Funding: Agendia, Amgen, Aristo, AstraZeneca, Boehringer Ingelheim, Carl Zeiss, Celgene, Daiichi Sankyo, Eisai, Exact Sciences, Genomic Health, Gilead, GSK, Hexal, Lilly, Medstrom Medical Medical, MSD, Mundipharma, Mylan, Nanostring, Novartis, Odonate, Paxman, Palleos, Pfizer, Pierre Fabre, Puma Bio, Riemser, Roche, Sandoz/Hexal, Sanofi Genentech, Seagen, Tesaro Bio, Teva, Veracyte, Viatris; Financial Interests, Personal, Other: Westdeutsche Studiengruppe GmbH. All other authors have declared no conflicts of interest.