Actively Recruiting
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Led by Hoffmann-La Roche · Updated on 2026-03-16
792
Participants Needed
45
Research Sites
652 weeks
Total Duration
On this page
Sponsors
H
Hoffmann-La Roche
Lead Sponsor
G
Gilead Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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, six 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, and 6 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.
CONDITIONS
Official Title
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Ability to follow the study protocol as judged by the investigator
- Diagnosis of metastatic or inoperable locally advanced breast cancer
- At least one measurable tumor lesion according to RECIST v1.1 criteria
- Life expectancy of at least 3 months
- Tumor accessible for biopsy or availability of suitable archival tissue
- Availability of a tumor specimen suitable for biomarker analysis
- Adequate blood counts and organ function within 14 days before starting treatment
- For women who can have children: agreement to use contraception or abstain from heterosexual intercourse, and to avoid breastfeeding and egg donation
- For men: agreement to use contraception or abstain from heterosexual intercourse, and to avoid sperm donation
You will not qualify if you...
- Prior treatment with immune checkpoint therapies or T-cell co-stimulating agents
- Biologic cancer treatment within 2 weeks before starting study treatment
- Other systemic treatment for triple-negative breast cancer within 2 weeks or 5 drug half-lives before starting treatment
- Use of systemic immunosuppressive medications within 2 weeks before starting treatment or expected need during the study
- Eligibility only for the control arm
- Unresolved side effects from previous cancer treatments worse than Grade 1 (except alopecia and certain neuropathies)
- Treatment with investigational drugs within 28 days before starting treatment
- Uncontrolled pleural, pericardial effusions, or ascites needing frequent drainage
- Uncontrolled tumor-related pain
- Symptomatic, untreated, or progressing central nervous system metastases
- History of leptomeningeal disease
- Active or past autoimmune disease or immune deficiency
- History or evidence of lung diseases like pneumonitis or pulmonary fibrosis
- Active tuberculosis infection
- Severe infection within 4 weeks before starting treatment
- Use of therapeutic antibiotics within 2 weeks before starting treatment
- Significant heart disease
- Previous allogeneic stem cell or solid organ transplant
- Other cancers within 2 years except those with very low risk of spread or death
- Pregnancy, breastfeeding, or planning pregnancy during the study
AI-Screening
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Trial Site Locations
Total: 45 locations
1
City of Hope
Duarte, California, United States, 91010
Completed
2
University of California San Diego Medical Center
La Jolla, California, United States, 92093
Completed
3
Stanford Cancer Institute
Stanford, California, United States, 94305
Withdrawn
4
Rocky Mountain Cancer Center - Longmont
Longmont, Colorado, United States, 80501
Completed
5
H. Lee Moffitt Cancer Center and Research Inst.
Tampa, Florida, United States, 33612
Completed
6
Hackensack Univ Medical Center
Hackensack, New Jersey, United States, 07601
Withdrawn
7
Regional Cancer Care Associates, LLC
Howell Township, New Jersey, United States, 07731
Withdrawn
8
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Withdrawn
9
NYU Langone Medical Center
New York, New York, United States, 10016
Withdrawn
10
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Withdrawn
11
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Withdrawn
12
Tennessee Oncology - Chattanooga Oncology & Hematology Associates
Chattanooga, Tennessee, United States, 37404
Actively Recruiting
13
The West Clinic
Germantown, Tennessee, United States, 38138
Actively Recruiting
14
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37203
Actively Recruiting
15
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Actively Recruiting
16
Texas Oncology-Plano East
Plano, Texas, United States, 75075-7787
Withdrawn
17
Peter MacCallum Cancer Centre-East Melbourne
Melbourne, Victoria, Australia, 3000
Actively Recruiting
18
Fiona Stanley Hospital - Medical Oncology
Murdoch, Western Australia, Australia, 6150
Actively Recruiting
19
Centre Léon Bérard
Lyon, France, 69008
Active, Not Recruiting
20
Institut régional du Cancer Montpellier
Montpellier, France, 34298
Withdrawn
21
Institut Universitaire du Cancer de Toulouse-Oncopole
Toulouse, France, 31059
Actively Recruiting
22
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
23
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
Actively Recruiting
24
Universitätsklinikum Essen
Essen, Germany, 45147
Actively Recruiting
25
Rambam Medical Center
Haifa, Israel, 3109601
Actively Recruiting
26
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Actively Recruiting
27
Hadassah University Medical Center
Jerusalem, Israel, 91120
Actively Recruiting
28
Rabin MC
Petah Tikva, Israel, 55900
Actively Recruiting
29
Sheba Medical Center
Ramat Gan, Israel, 5262100
Actively Recruiting
30
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel, 6423906
Actively Recruiting
31
Assuta Medical Centers
Tel Aviv, Israel, 69710
Actively Recruiting
32
National Cancer Center Clinical Trials Center / Center for Breast Cancer
Goyang-si, South Korea, 410-769
Actively Recruiting
33
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
34
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
35
University of Ulsan College of Medicine - Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
36
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
37
Hospital Universitario Virgen Macarena
Seville, Sevilla, Spain, 41009
Actively Recruiting
38
Hospital del Mar
Barcelona, Spain, 08003
Actively Recruiting
39
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, Spain, 08035
Actively Recruiting
40
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Actively Recruiting
41
Centro Integral Oncológico Clara Campal Ensayos Clínicos START
Madrid, Spain, 28050
Actively Recruiting
42
National Cheng Kung University Hospital
Tainan, Taiwan, 704302
Actively Recruiting
43
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
44
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Completed
45
Barts Health NHS Trust - St Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
Completed
Research Team
R
Reference Study ID Number: CO40115 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
19
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