Standardized Definitions for Efficacy End Points in Neoadjuvant Breast Cancer Clinical Trials: NeoSTEEP.

Autor: Litton JK; Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX., Regan MM; Division of Biostatistics, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA., Pusztai L; Breast Medical Oncology, Yale Cancer Center, Yale School of Medicine, New Haven, CT., Rugo HS; University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco, CA., Tolaney SM; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA., Garrett-Mayer E; American Society of Clinical Oncology, Alexandria, VA., Amiri-Kordestani L; US Food and Drug Administration, Silver Spring, MD., Basho RK; The Lawrence J. Ellison Institute for Transformative Medicine, Los Angeles, CA., Best AF; Biometric Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Rockville, MD., Boileau JF; Department of Surgery, McGill University, Montreal, Quebec, Canada., Denkert C; Institute of Pathology, Philipps University Marburg and University Hospital Marburg (UKGM), Marburg, Germany., Foster JC; Biometric Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Rockville, MD., Harbeck N; The Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Munich, LMU University Hospital, Munich, Germany., Jacene HA; Department of Radiology, Brigham and Women's Hospital, Boston, MA., King TA; Division of Breast Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, MA., Mason G; The Inflammatory Breast Cancer Research Foundation, Broadway, VA., O'Sullivan CC; Department of Oncology, Mayo Clinic, Rochester, MN., Prowell TM; US Food and Drug Administration, Silver Spring, MD.; Women's Malignancies Disease Group, Johns Hopkins Kimmel Comprehensive Cancer Center, Baltimore, MD., Richardson AL; Department of Pathology, John Hopkins Medicine, Baltimore, MD., Sepulveda KA; Department of Radiology, Baylor College of Medicine, Houston, TX., Smith ML; Research Advocacy Network, Plano, TX., Tjoe JA; Division of Breast Surgery, Department of Surgery, Novant Health, Greensboro, NC., Turashvili G; Department of Pathology and Laboratory Medicine, Emory University Hospital, Atlanta, GA., Woodward WA; Department of Breast Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX., Butler LP; The Emmes Corporation, Rockville, MD., Schwartz EI; Coordinating Center for Clinical Trials, National Cancer Institute, Rockville, MD., Korde LA; Cancer Therapy and Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Rockville, MD.

Publikováno v: Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2023 Sep 20; Vol. 41 (27), pp. 4433-4442. Date of Electronic Publication: 2023 Jul 11.

The (R)evolution of Social Media in Oncology: Engage, Enlighten, and Encourage.

Autor: Morgan G; Skåne University Hospital, Division of Medical/Radiation Oncology and Hematology, Lund, Sweden., Agarwal N; Medical Oncology, Huntsman Cancer Institute, University of Utah (NCI-Comprehensive Cancer Center), Salt Lake City, Utah., Choueiri TK; Dana-Farber Cancer Institute, Boston, Massachusetts., Dizon DS; Lifespan Cancer Institute, Providence, Rhode Island., Hamilton EP; Sarah Cannon Research Institute/Tennessee Oncology, Nashville Tennessee., Markham MJ; University of Florida, College of Medicine, Gainesville, Florida., Lewis M; Intermountain Healthcare, Murray, Utah., Prowell TM; Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland., Rugo HS; University of California, San Francisco, San Francisco, California., Subbiah V; The University of Texas MD Anderson Cancer Center, Houston, Texas., West HL; AccessHope/City of Hope, Los Angeles, California.

Publikováno v: Cancer discovery [Cancer Discov] 2022 Jul 06; Vol. 12 (7), pp. 1620-1624.

U.S. FDA Drug Approvals for Breast Cancer: A Decade in Review.

Autor: Arora S; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland., Narayan P; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland., Osgood CL; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland., Wedam S; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland., Prowell TM; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland., Gao JJ; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Shah M; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland., Krol D; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland., Wahby S; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland., Royce M; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland., Ghosh S; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland., Philip R; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland., Ison G; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland., Berman T; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland., Brus C; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland., Bloomquist EW; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland., Fiero MH; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland., Tang S; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland., Pazdur R; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Ibrahim A; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland., Amiri-Kordestani L; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland., Beaver JA; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.

Publikováno v: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2022 Mar 15; Vol. 28 (6), pp. 1072-1086.

Overall survival in patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer treated with a cyclin-dependent kinase 4/6 inhibitor plus fulvestrant: a US Food and Drug Administration pooled analysis.

Autor: Gao JJ; Oncology Center of Excellence, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA. Electronic address: jennifer.gao@fda.hhs.gov., Cheng J; Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Prowell TM; Office of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Bloomquist E; Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Tang S; Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Wedam SB; Office of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Royce M; Office of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Krol D; Office of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Osgood C; Office of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Ison G; Office of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Sridhara R; Oncology Center of Excellence, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Pazdur R; Oncology Center of Excellence, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA; Office of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Beaver JA; Oncology Center of Excellence, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA; Office of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Amiri-Kordestani L; Office of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

Publikováno v: The Lancet. Oncology [Lancet Oncol] 2021 Nov; Vol. 22 (11), pp. 1573-1581. Date of Electronic Publication: 2021 Oct 14.

FDA Approval Summary: Alpelisib Plus Fulvestrant for Patients with HR-positive, HER2-negative, PIK3CA-mutated, Advanced or Metastatic Breast Cancer.

Autor: Narayan P; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. preeti.narayan@fda.hhs.gov., Prowell TM; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Gao JJ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Fernandes LL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Li E; Oncology Center of Excellence Summer Scholars Program, Silver Spring, Maryland., Jiang X; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Qiu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Fan J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Song P; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Yu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Zhang X; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., King-Kallimanis BL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Chen W; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Ricks TK; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Gong Y; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Wang X; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Windsor K; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Rhieu SY; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Geiser G; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Banerjee A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Chen X; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Reyes Turcu F; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland., Chatterjee DK; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland., Pathak A; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland., Seidman J; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland., Ghosh S; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland., Philip R; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland., Goldberg KB; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Kluetz PG; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Tang S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Amiri-Kordestani L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Theoret MR; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Pazdur R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Beaver JA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.

Publikováno v: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2021 Apr 01; Vol. 27 (7), pp. 1842-1849. Date of Electronic Publication: 2020 Nov 09.