A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Pacjent musi mieć ukończone 18 lat.
- •Pacjent musi być w dobrym stanie ogólnym (skala ECOG 0-1).
- •Choroba musi być zaawansowana lub rozsiana i nieoperacyjna.
- •Rak musi być możliwy do zmierzenia i być gruczolakorakiem.
- •Pacjent musi przeżyć co najmniej 3 miesiące.
- •Guz musi nadawać się do biopsji lub być dostępny archiwalny materiał.
- •Pacjent musi mieć dostępny reprezentatywny fragment guza do badań laboratoryjnych.
- •Kobiety i mężczyźni w wieku rozrodczym muszą stosować skuteczne metody antykoncepcji.
✗ Disqualifies
- •Pacjent nie mógł wcześniej przyjmować pewnych leków immunoterapeutycznych.
- •Pacjent nie mógł przyjmować innych leków biologicznych lub systemowych na raka piersi w określonym czasie przed badaniem.
- •Pacjent nie mógł przyjmować leków immunosupresyjnych (np. sterydów).
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- June 17, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (46)
City of Hope
Duarte, United States
University of California San Diego Medical Center
La Jolla, United States
Stanford Cancer Institute
Stanford, United States
Rocky Mountain Cancer Center - Longmont
Longmont, United States
H. Lee Moffitt Cancer Center and Research Inst.
Tampa, United States
Metro-Minnesota Community Oncology Research Consortium
Saint Paul, United States
Hackensack Univ Medical Center
Hackensack, United States
Regional Cancer Care Associates, LLC
Howell Township, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, United States
NYU Langone Medical Center
New York, United States
Thomas Jefferson University Hospital
Philadelphia, United States
University of Pittsburgh Medical Center
Pittsburgh, United States
Tennessee Oncology - Chattanooga Oncology & Hematology Associates
Chattanooga, United States
The West Clinic
Germantown, United States
Tennessee Oncology PLLC
Nashville, United States
Vanderbilt University Medical Center
Nashville, United States
Texas Oncology-Plano East
Plano, United States
Peter MacCallum Cancer Centre-East Melbourne
Melbourne, Australia
Fiona Stanley Hospital - Medical Oncology
Murdoch, 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
Erlangen, Germany
Universitätsklinikum Essen
Essen, Germany
Rambam Medical Center
Haifa, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Hadassah University Medical Center
Jerusalem, Israel
Rabin MC
Petah Tikva, Israel
Sheba Medical Center
Ramat Gan, Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel
Assuta Medical Centers
Tel Aviv, Israel
National Cancer Center Clinical Trials Center / Center for Breast Cancer
Goyang-si, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
University of Ulsan College of Medicine - Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Hospital Universitario Virgen Macarena
Seville, Spain
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
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Barts Health NHS Trust - St Bartholomew's Hospital
London, United Kingdom
Trial contact
Reference Study ID Number: CO40115 https://forpatients.roche.com/
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.