A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Start Date
3/30/2018
Completion Date
9/30/2030
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, seven 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-naïve cohort). Cohort 3, 5, 6 and 7 will consist of participants with locally advanced or metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative disease with one or more PIK3CA mutations. Cohort 4 will consist of participants with locally advanced or metastatic HER2+ /HER2-low disease with one or more PIK3CA mutations 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). During Stage 2, 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, provided Stage 2 is open for enrollment and all eligibility criteria are met.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Capecitabine
Atezolizumab
Ipatasertib
SGN-LIV1A
Bevacizumab
Chemotherapy (Gemcitabine + Carboplatin or Eribulin)
Selicrelumab
Tocilizumab
Nab-Paclitaxel
Sacituzumab Govitecan
Abemaciclib
Fulvestrant
Ribociclib (Dose #1)
Inavolisib (Dose #1)
Trastuzumab Deruxtecan
Ribociclib (Dose #2)
Letrozole
Inavolisib (Dose #2)
Empagliflozin
Palbociclib
Metformin
Atirmociclib
Giredestrant
Conditions
Locations
City of Hope
Duarte, California 91010
United States
University of California San Diego Medical Center
La Jolla, California 92093
United States
Stanford Cancer Institute
Stanford, California 94305
United States
Rocky Mountain Cancer Center - Longmont
Longmont, Colorado 80501
United States
H. Lee Moffitt Cancer Center and Research Inst.
Tampa, Florida 33612
United States
Metro-Minnesota Community Oncology Research Consortium
Saint Paul, Minnesota 55101-2502
United States
Renown Regional Medical Center
Reno, Nevada 89502-1576
United States
Hackensack Univ Medical Center
Hackensack, New Jersey 07601
United States
Regional Cancer Care Associates, LLC
Howell Township, New Jersey 07731
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
United States
NYU Langone Medical Center
New York, New York 10016
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
United States
Tennessee Oncology - Chattanooga Oncology & Hematology Associates
Chattanooga, Tennessee 37404
United States
The West Clinic
Germantown, Tennessee 38138
United States
Tennessee Oncology PLLC
Nashville, Tennessee 37203
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37212
United States
Texas Oncology-Plano East
Plano, Texas 75075-7787
United States
Peter MacCallum Cancer Centre-East Melbourne
Melbourne, Victoria 3000
Australia
Fiona Stanley Hospital - Medical Oncology
Murdoch, Western Australia 6150
Australia
Centre Léon Bérard
Lyon, 69008
France
Institut régional du Cancer Montpellier
Montpellier, 34298
France
Institut Universitaire du Cancer de Toulouse-Oncopole
Toulouse, 31059
France
Gustave Roussy
Villejuif, 94805
France
Universitätsklinikum Erlangen
Erlangen, 91054
Germany
Universitätsklinikum Essen
Essen, 45147
Germany
Rambam Medical Center
Haifa, 3109601
Israel
Shaare Zedek Medical Center
Jerusalem, 9103102
Israel
Hadassah University Medical Center
Jerusalem, 91120
Israel
Rabin MC
Petah Tikva, 55900
Israel
Sheba Medical Center
Ramat Gan, 5262100
Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, 6423906
Israel
Assuta Medical Centers
Tel Aviv, 69710
Israel
National Cancer Center Clinical Trials Center / Center for Breast Cancer
Goyang-si, 410-769
South Korea
Seoul National University Hospital
Seoul, 03080
South Korea
Severance Hospital
Seoul, 03722
South Korea
Asan Medical Center
Seoul, 05505
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
Hospital Universitario Virgen Macarena
Seville, Sevilla 41009
Spain
Hospital del Mar
Barcelona, 08003
Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035
Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034
Spain
Centro Integral Oncológico Clara Campal Ensayos Clínicos START
Madrid, 28050
Spain
National Cheng Kung University Hospital
Tainan, 704302
Taiwan
National Taiwan University Hospital
Taipei, 100
Taiwan
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
United Kingdom
Barts Health NHS Trust - St Bartholomew's Hospital
London, EC1A 7BE
United Kingdom