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Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer
NCT03971409 · View on ClinicalTrials.gov ↗
Study Summary
This phase II trial studies how well the combination of avelumab with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works in treating patients with triple negative breast cancer that is stage IV or is not able to be removed by surgery (unresectable) and has come back (recurrent). Immunotherapy with checkpoint inhibitors like avelumab require activation of the patient's immune system. This trial includes a two week induction or lead-in of medications that can stimulate the immune system. It is our hope that this induction will improve the response to immunotherapy with avelumab. One treatment, sacituzumab Govitecan, is a monoclonal antibody called sacituzumab linked to a chemotherapy drug called SN-38. Sacituzumab govitecan is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as Tumor-associated calcium signal transducer 2 (TROP2) receptors, and delivers SN-38 to kill them. Another treatment, liposomal doxorubicin, is a form of the anticancer drug doxorubicin that is contained in very tiny, fat-like particles. It may have fewer side effects and work better than doxorubicin, and may enhance factors associated with immune response. The third medication is called binimetinib, which may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and may help activate the immune system. It is not yet known whether giving avelumab in combination with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan will work better in treating patients with triple negative breast cancer.
Conditions Studied
Interventions
- DRUG Liposomal Doxorubicin
- DRUG Avelumab
- DRUG Binimetinib
- BIOLOGICAL Anti-OX40 Antibody PF-04518600
- BIOLOGICAL Utomilumab
Study Locations (12)
North Carolina
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill
- Duke Cancer Institute — Durham
Alabama
- O'Neal Comprehensive Cancer Center — Birmingham
California
- University of California, San Francisco — San Francisco
District of Columbia
- Georgetown University — Washington D.C.
Illinois
- University of Chicago Medicine Comprehensive Cancer Center — Evergreen Park
Maryland
- Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University — Baltimore
Massachusetts
- Dana-Farber Cancer Institute — Boston
Minnesota
- Mayo Clinic — Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2019-07-08 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03971409
The ClinicalTrials.gov registry entry for NCT03971409 describes a study currently listed as recruiting. It is categorized as Phase 2, 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 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Laura Huppert, MD, BA, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 9 conditions, with Invasive Breast Carcinoma appearing as the primary indexed condition, and to 5 interventions — of which Liposomal Doxorubicin 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: NCT03971409 reports 12 study locations spanning 11 distinct geographic areas — top geographies include North Carolina, Alabama, California. 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 NCT03971409 about?
NCT03971409 is a clinical study titled "Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer". This phase II trial studies how well the combination of avelumab with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works in treating patients with triple negative breast cancer that is stage IV or is not able to be removed by surgery (u...
What is the current status of trial NCT03971409?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2019-07-08. Estimated completion is 2026-06-30.
What conditions does trial NCT03971409 study?
This clinical trial studies the following conditions: Invasive Breast Carcinoma, Stage IV Breast Cancer, Recurrent Breast Carcinoma, Stage IIIA Breast Cancer, Stage IIIB 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 NCT03971409?
The interventions under investigation include: Liposomal Doxorubicin (DRUG), Avelumab (DRUG), Binimetinib (DRUG), Anti-OX40 Antibody PF-04518600 (BIOLOGICAL), Utomilumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03971409?
This trial is sponsored by Laura Huppert, MD, BA, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03971409 being conducted?
This trial has 12 study locations across Alabama, California, District of Columbia, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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