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A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
NCT03424005 · View on ClinicalTrials.gov ↗
Study 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, 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 Studied
Interventions
- DRUG Bevacizumab
- DRUG Capecitabine
- DRUG Atezolizumab
- DRUG Ipatasertib
- DRUG SGN-LIV1A
Study Locations (20)
Tennessee
- Tennessee Oncology - Chattanooga Oncology & Hematology Associates — Chattanooga
- The West Clinic — Germantown
- Tennessee Oncology PLLC — Nashville
- Vanderbilt University Medical Center — Nashville
California
- City of Hope — Duarte
- University of California San Diego Medical Center — La Jolla
- Stanford Cancer Institute — Stanford
New Jersey
- Hackensack Univ Medical Center — Hackensack
- Regional Cancer Care Associates, LLC — Howell Township
- Rutgers Cancer Institute of New Jersey — New Brunswick
Pennsylvania
- Thomas Jefferson University Hospital — Philadelphia
- University of Pittsburgh Medical Center — Pittsburgh
Other
- Centre Léon Bérard — Lyon
- Institut régional du Cancer Montpellier — Montpellier
Colorado
- Rocky Mountain Cancer Center - Longmont — Longmont
Florida
- H. Lee Moffitt Cancer Center and Research Inst. — Tampa
New York
- NYU Langone Medical Center — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 792 participants |
| Start Date | 2018-03-30 |
| Est. Completion | 2030-09-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03424005
The ClinicalTrials.gov registry entry for NCT03424005 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 792 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 5 interventions — of which Bevacizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03424005 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Tennessee, California, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03424005 about?
NCT03424005 is a clinical study titled "A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer". 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 ...
What is the current status of trial NCT03424005?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 792 participants. The study started on 2018-03-30. Estimated completion is 2030-09-30.
What conditions does trial NCT03424005 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03424005?
The interventions under investigation include: Bevacizumab (DRUG), Capecitabine (DRUG), Atezolizumab (DRUG), Ipatasertib (DRUG), SGN-LIV1A (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03424005?
This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03424005 being conducted?
This trial has 20 study locations across California, Colorado, Florida, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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