Study of Multiple Treatment Combinations for Metastatic Breast Cancer
This study is looking at several different treatment combinations for people with metastatic (cancer that has spread) or locally advanced breast cancer. It's testing the safety and effectiveness of drugs like Capecitabine, Atezolizumab, Ipatasertib, SGN-LIV1A, and Bevacizumab. Some of these treatments work by targeting specific biomarkers (like HER2 or PD-L1) or by using immunotherapy (which helps your body's immune system fight cancer). To join, you must be at least 18 years old and have metastatic or inoperable breast cancer. The study will measure how many people respond to the treatments (Objective Response Rate) over a long period, up to about 12 years. The current status of the study is unclear.
- Study design
- This is an interventional study planning to enroll 1132 participants. It is an umbrella study, meaning it evaluates multiple treatment combinations in different groups of patients.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed from baseline until disease progression or loss of clinical benefit, which could be up to approximately 12 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT03424005
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentHoffmann-La Roche
~1,132 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:CapecitabineAtezolizumabIpatasertibSGN-LIV1ABevacizumabChemotherapy (Gemcitabine + Carboplatin or Eribulin)
At a glance
Recruiting sites
33 of 49 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR)
Measured over Baseline until disease progression or loss of clinical benefit (up to approximately 12 years)
Conditions
Where it's being run
49 sites across 21 statesIsrael7
South Korea5
California4
Tennessee4
France4
Spain4
New Jersey3
Pennsylvania2
Study leadership
- Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche
Who to contact
Reference Study ID Number: CO40115 https://forpatients.roche.com/ No attachments to email below.
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Age \>/= 18 years at the time of signing Informed Consent Form
Eastern cooperative oncology group (ECOG) performance status of 0 or 1
Able to comply with the study protocol, in the investigator's judgment
Metastatic or inoperable locally advanced adenocarcinoma of the breast
Measurable disease (at least one target lesion) according to RECIST v1.1
Life expectancy \>/= 3 months, as determined by the investigator
Tumor accessible for biopsy, unless archival tissue is available
Availability of a representative tumor specimen that is suitable for biomarker analysis via central testing
Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from breastfeeding and donating eggs, as outlined for each specific treatment arm
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm
Exclusion
Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, CD40 agonists or interleukin-2 (IL-2) or IL-2-like compounds
Biologic treatment (e.g., bevacizumab) within 2 weeks prior to initiation of study treatment, or other systemic treatment for TNBC within 2 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor alpha agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study
Eligibility only for the control arm
Adverse events from prior anti-cancer therapy that have not resolved to Grade \</= 1 or better with the exception of alopecia of any grade and Grade \</= 2 peripheral neuropathy
Treatment with investigational therapy within 28 days prior to initiation of study treatment
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
Uncontrolled tumor-related pain
Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
History of leptomeningeal disease
Active or history of autoimmune disease or immune deficiency
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
Active tuberculosis
Severe infection within 4 weeks prior to initiation of study treatment
Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
Significant cardiovascular disease
Prior allogeneic stem cell or solid organ transplantation
History of malignancy other than breast cancer within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death
Pregnancy or breastfeeding, or intention of becoming pregnant during the study
What this trial measures
- Objective Response Rate (ORR)Baseline until disease progression or loss of clinical benefit (up to approximately 12 years)