Bringing safe and effective therapies to premenopausal women with breast cancer: efforts to broaden eligibility criteria

J J Gao¹, D Krol², P Narayan², F Cardoso³, M M Regan⁴, M P Goetz⁵, S A Hurvitz⁶, L Mauro⁷, C Hodgdon⁸, C P Miller², B Booth², E Bloomquist², G Ison², C Osgood², V Bhatnagar⁹, L Fashoyin-Aje¹⁰, R Pazdur¹⁰, L Amiri-Kordestani², J A Beaver¹⁰

Affiliations

¹ Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, USA. Electronic address: Jennifer.gao@fda.hhs.gov.
² Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA.
³ Breast Unit, Champalimaud Clinical Center/Champalimaud Foundation and ABC Global Alliance, Lisbon, Portugal.
⁴ Division of Biostatistics, Dana-Farber Cancer Institute, Harvard Medical School, Boston, USA.
⁵ Department of Oncology and Pharmacology, Mayo Clinic, Rochester, USA.
⁶ David Geffen School of Medicine, University of California Los Angeles, Jonsson Comprehensive Cancer Center, Los Angeles, USA.
⁷ Inova Schar Cancer Institute, Fairfax, USA.
⁸ Patient Advocate.
⁹ Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, USA.
¹⁰ Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, USA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA.

PMID: 33991601
DOI: 10.1016/j.annonc.2021.05.356

Free article

Editorial

Bringing safe and effective therapies to premenopausal women with breast cancer: efforts to broaden eligibility criteria

J J Gao et al. Ann Oncol. 2021 Aug.

Free article

. 2021 Aug;32(8):950-953.

doi: 10.1016/j.annonc.2021.05.356. Epub 2021 May 13.

Authors

Affiliations

¹ Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, USA. Electronic address: Jennifer.gao@fda.hhs.gov.
² Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA.
³ Breast Unit, Champalimaud Clinical Center/Champalimaud Foundation and ABC Global Alliance, Lisbon, Portugal.
⁴ Division of Biostatistics, Dana-Farber Cancer Institute, Harvard Medical School, Boston, USA.
⁵ Department of Oncology and Pharmacology, Mayo Clinic, Rochester, USA.
⁶ David Geffen School of Medicine, University of California Los Angeles, Jonsson Comprehensive Cancer Center, Los Angeles, USA.
⁷ Inova Schar Cancer Institute, Fairfax, USA.
⁸ Patient Advocate.
⁹ Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, USA.
¹⁰ Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, USA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA.

PMID: 33991601
DOI: 10.1016/j.annonc.2021.05.356

Erratum in

Corrigendum to "Bringing safe and effective therapies to premenopausal women with breast cancer: efforts to broaden eligibility criteria": [Annals of Oncology 32 (2021) 950-953].
Gao JJ, Krol D, Narayan P, Cardoso F, Regan MM, Goetz MP, Hurvitz SA, Mauro L, Hodgdon C, Miller CP, Booth B, Bloomquist E, Ison G, Osgood C, Bhatnagar V, Fashoyin-Aje L, Pazdur R, Amiri-Kordestani L, Beaver JA. Gao JJ, et al. Ann Oncol. 2022 Mar;33(3):356. doi: 10.1016/j.annonc.2022.01.001. Epub 2022 Jan 7. Ann Oncol. 2022. PMID: 35012799 No abstract available.

No abstract available

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Conflict of interest statement

Disclosure FC: consulting/advisory for Amgen, Astellas/Medivation, AstraZeneca, Celgene, Daiichi-Sankyo, Eisai, GE Oncology, Genentech, GlaxoSmithKline (GSK), Macrogenics, Medscape, Merck-Sharp, Merus BV, Mylan, Mundipharma, Novartis, Pfizer, Pierre-Fabre, prIME Oncology, Roche, Sanofi, Samsung Bioepis, Seattle Genetics, Teva. MMR: research resources (to institution) for clinical trials from Novartis, Pfizer, Ipsen, TerSera, Merck, Ferring, Pierre Fabre, Roche, AstraZeneca, Bristol-Myers Squibb, Bayer; consulting or advisory role (personal) to Bristol-Myers Squibb, Tolmar Pharmaceuticals; honoraria from WebMD. MPG: reports consulting fees (all to institution) from Eagle Pharmaceuticals, Eli Lilly, Biovica, Novartis, Sermonix, Context Pharm, Pfizer, and Biotheranostics. Research funding from the National Cancer Institute, National Institutes of Health, Department of Defense, Mayo Development, Eli Lilly, Pfizer, Alliance Foundation Trials, Sermonix Pharmaceutical, Translational Breast Cancer Research Consortium, and Minnesota Partnership for Biotechnology and Medical Genomics. SH: contracted research (to institution): Ambrx, Amgen, AstraZeneca, Arvinas, Bayer, Daiichi-Sankyo, Genentech/Roche, Gilead, GSK, Immunomedics, Lilly, Macrogenics, Novartis, Pfizer, OBI Pharma, Pieris, PUMA, Radius, Sanofi, Seattle Genetics, Dignitana, Zymeworks, Phoenix Molecular Designs, Ltd. Travel: Lilly (2019). LM: research resources (to institution) for clinical trials from AstraZeneca, Eli Lilly and Company, Hoffman-La Roche, Pfizer, Radius Pharmaceuticals; consulting or advisory role (personal) to BioTheranostics. CH: Roche/Genentech (honoraria, consulting/advisory), Pfizer (consulting/advisory), Johns Hopkins Hospital (consulting/advisory), NIH/NCI Cancer Moonshot (consulting/advisory), Eli Lilly (travel, accommodations, expenses). All other authors have declared no conflicts of interest.

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Bringing safe and effective therapies to premenopausal women with breast cancer: efforts to broaden eligibility criteria

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Bringing safe and effective therapies to premenopausal women with breast cancer: efforts to broaden eligibility criteria

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