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A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
NCT03280563 · View on ClinicalTrials.gov ↗
Study Summary
This study is designed to evaluate the efficacy, safety, and pharmacokinetics of several immunotherapy-based combination treatments in participants with inoperable locally advanced or metastatic HR-positive, HER2-negative breast cancer who have progressed during or following treatment with a cyclin-dependent kinase (CDK) 4/6 inhibitor in the first- or second-line setting, such as palbociclib, ribociclib, or abemaciclib. The study will be performed in two stages. During Stage 1, participants will be randomized to fulvestrant (control) or an atezolizumab-containing doublet or triplet combination. Those who experience disease progression, loss of clinical benefit, or unacceptable toxicity may be eligible to receive a new triplet combination treatment in Stage 2 until loss of clinical benefit or unacceptable toxicity. New treatment arms may be added and/or existing treatment arms may be closed during the course of the study on the basis of ongoing clinical efficacy and safety as well as the current treatments available.
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG Exemestane
- DRUG Fulvestrant
- DRUG Entinostat
- DRUG Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody
Study Locations (20)
Other
- Rambam Medical Center — Haifa
- Shaare Zedek Medical Center — Jerusalem
- Rabin Medical Center-Beilinson Campus — Petah Tikva
- Sheba Medical Center — Ramat Gan
- Tel Aviv Sourasky Medical Center — Tel Aviv
- National Cancer Center — Gyeonggi-do
California
- UCSF Helen Diller Family CCC — San Francisco
- Stanford Cancer Institute — Stanford
- Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center — Torrance
- Wellness Oncology and Hematology - Main Office — West Hills
Pennsylvania
- UPMC Pinnacle Health System — Harrisburg
- Thomas Jefferson University Hospital — Philadelphia
- Univ of Pittsburgh Sch of Med — Pittsburgh
Alabama
- University of Alabama at Birmingham — Birmingham
Georgia
- Northwest Georgia Oncology Centers PC - Marietta — Marietta
Maryland
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore
New York
- Memorial Sloan Kettering Cancer Center — New York
North Carolina
- Levine Cancer Institute — Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2017-12-22 |
| Est. Completion | 2024-09-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03280563
The ClinicalTrials.gov registry entry for NCT03280563 describes a study currently listed as completed. 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 144 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 Breast Neoplasms 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: NCT03280563 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, California, Pennsylvania. 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 NCT03280563 about?
NCT03280563 is a clinical study titled "A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer". This study is designed to evaluate the efficacy, safety, and pharmacokinetics of several immunotherapy-based combination treatments in participants with inoperable locally advanced or metastatic HR-positive, HER2-negative breast cancer who have progressed during or following treatment with a cyclin-...
What is the current status of trial NCT03280563?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 144 participants. The study started on 2017-12-22. Estimated completion is 2024-09-26.
What conditions does trial NCT03280563 study?
This clinical trial studies the following conditions: Breast Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03280563?
The interventions under investigation include: Bevacizumab (DRUG), Exemestane (DRUG), Fulvestrant (DRUG), Entinostat (DRUG), Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03280563?
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 NCT03280563 being conducted?
This trial has 20 study locations across Alabama, California, Georgia, Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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