Spots Global Cancer Trial Database for A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
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Trial Identification
Brief Title: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Official Title: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Treatment Combinations In Patients With Metastatic Breast Cancer (Morpheus-panBC)
Study ID: NCT03424005
Conditions
Study Description
Brief Summary: This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages. During Stage 1, four cohorts will be enrolled in parallel in this study: Cohort 1 will consist of Programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line \[1L\] PD-L1+ cohort). Cohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line \[2L\] CIT-naive cohort). Cohort 3 will consist of participants with locally-advanced or metastatic HR+, HER2-negative disease with PIK3CA mutation who may or may not have had disease progression during or following previous lines of treatment for metastatic disease (HR+cohort). Cohort 4 will consist of participants with locally-advanced or metastatic HER2+ /HER2-low disease with PIK3CA mutation who had disease progression on standard-of-care therapies (HER2+ /HER2-low cohort). In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). In addition, participants in the 2L CIT-naïve cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination (Stage 2), provided Stage 2 is open for enrollment.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope, Duarte, California, United States
University of California San Diego Medical Center; Moores Cancer Center, La Jolla, California, United States
Stanford Cancer Institute, Stanford, California, United States
Rocky Mountain Cancer Center - Longmont, Longmont, Colorado, United States
H. Lee Moffitt Cancer Center and Research Inst., Tampa, Florida, United States
Hackensack Univ Medical Center; John Theurer Cancer Ctr, Hackensack, New Jersey, United States
Regional Cancer Care Associates, LLC, Howell, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
NYU Langone Medical Center; NYU Perlmutter Cancer Center, New York, New York, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
The West Clinic; West Cancer Center, Germantown, Tennessee, United States
Vanderbilt University Medical Center; Vanderbilt University, Nashville, Tennessee, United States
Texas Oncology-Plano East, Plano, Texas, United States
Peter MacCallum Cancer Centre-East Melbourne, Melbourne, Victoria, Australia
Fiona Stanley Hospital - Medical Oncology, Murdoch, Western Australia, Australia
Centre Léon Bérard, Lyon, , France
Institut régional du Cancer Montpellier, Montpellier, , France
Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse, , France
Gustave Roussy, Villejuif, , France
Universitätsklinikum Erlangen; Frauenklinik, Erlangen, , Germany
Universitätsklinikum Essen, Essen, , Germany
Shaare Zedek Medical Center, Jerusalem, , Israel
Hadassah University Medical Center, Jerusalem, , Israel
Rabin MC; Davidof Center - Oncology Institute, Petach Tikva, , Israel
Sheba Medical Center, Ramat Gan, , Israel
Tel-Aviv Sourasky Medical Center, Tel Aviv, , Israel
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
University of Ulsan College of Medicine - Asan Medical Center, Seoul, , Korea, Republic of
Hospital del Mar, Barcelona, , Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona, Barcelona, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Centro Integral Oncológico Clara Campal Ensayos Clínicos START, Madrid, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Barts Health NHS Trust - St Bartholomew's Hospital, London, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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