Spots Global Cancer Trial Database for A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
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Trial Identification
Brief Title: A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
Official Title: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Hormone Receptor-Positive HER2-Negative Breast Cancer (MORPHEUS-HR+ Breast Cancer)
Study ID: NCT03280563
Conditions
Study Description
Brief Summary: This study is designed to evaluate the efficacy, safety, and pharmacokinetics of several immunotherapy-based combination treatments in participants with inoperable locally advanced or metastatic HR-positive, HER2-negative breast cancer who have progressed during or following treatment with a cyclin-dependent kinase (CDK) 4/6 inhibitor in the first- or second-line setting, such as palbociclib, ribociclib, or abemaciclib. The study will be performed in two stages. During Stage 1, participants will be randomized to fulvestrant (control) or an atezolizumab-containing doublet or triplet combination. Those who experience disease progression, loss of clinical benefit, or unacceptable toxicity may be eligible to receive a new triplet combination treatment in Stage 2 until loss of clinical benefit or unacceptable toxicity. New treatment arms may be added and/or existing treatment arms may be closed during the course of the study on the basis of ongoing clinical efficacy and safety as well as the current treatments available.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Cedars-Sinai Medical Center, Los Angeles, California, United States
UCSF Helen Diller Family CCC, San Francisco, California, United States
Stanford Cancer Institute, Stanford, California, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, California, United States
Wellness Oncology and Hematology - Main Office, West Hills, California, United States
Northwest Georgia Oncology Centers PC - Marietta, Marietta, Georgia, United States
Rush University Medical Center - Chicago, Chicago, Illinois, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Providence Cancer Center, Portland, Oregon, United States
UPMC Pinnacle Health System, Harrisburg, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Univ of Pittsburgh Sch of Med; Magee-Womens Hospital, Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Houston Methodist Hospital; Department of Pharmacy, Houston, Texas, United States
Northwest Medical Specialties, PLLC; Research Department, Tacoma, Washington, United States
Rambam Medical Center, Haifa, , Israel
Shaare Zedek Medical Center, Jerusalem, , Israel
Rabin Medical Center-Beilinson Campus; Davidof Institute, Petach Tikva, , Israel
Sheba Medical Center, Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center; Pharmacy, Tel Aviv, , Israel
National Cancer Center, Goyang-si, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
University of Ulsan College of Medicine - Asan Medical Center, Seoul, , Korea, Republic of
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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