OncoMatch/Clinical Trials/NCT03971409
Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer
Is NCT03971409 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for stage iii breast cancer.
Treatment: Anti-OX40 Antibody PF-04518600 · Avelumab · Binimetinib · Utomilumab · Liposomal Doxorubicin · Sacituzumab Govitecan — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: ESR1 negative (≤ 5% cells by IHC) (≤ 5% cells by IHC)
Estrogen receptor (ER)/progesterone receptor (PR)-negative (≤ 5% cells) by immunohistochemistry (IHC)
Required: PR (PGR) negative (≤ 5% cells by IHC) (≤ 5% cells by IHC)
Estrogen receptor (ER)/progesterone receptor (PR)-negative (≤ 5% cells) by immunohistochemistry (IHC)
Required: HER2 (ERBB2) negative (negative by IHC or FISH)
human epidermal grow (HER2) negative (by IHC or fluorescence in situ hybridization (FISH))
Required: PD-L1 (CD274) tested (known tumor/immune cell PD-L1 status by any assay)
Known tumor/immune cell PD-L1 status by any assay
Disease stage
Required: Stage IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: checkpoint inhibitor
Exception: ≤ 1 prior line of checkpoint inhibitor therapy in the metastatic setting allowed
More than 1 prior line of checkpoint inhibitor therapy in the metastatic setting
Cannot have received: chemotherapy
Exception: ≤ 2 lines of chemotherapy in the metastatic setting allowed
More than 2 lines of chemotherapy in the metastatic setting
Cannot have received: antibody-drug conjugate (sacituzumab govitecan)
Prior treatment with sacituzumab, govitecan
Lab requirements
Blood counts
ANC ≥ 1.0 x 10^9/L (may have received growth factor); Platelets ≥ 100 x 10^9/L; Hemoglobin ≥ 9 g/dL (may have been transfused)
Kidney function
Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 50 mL/min (Cockcroft-Gault equation)
Liver function
Total serum bilirubin ≤ 1.5 x ULN; AST/ALT ≤ 2.5 x ULN (or ≤ 5 x ULN if liver metastases are present)
Cardiac function
Cardiac ejection fraction at or above the institutional lower limit of normal, as assessed by echocardiogram or MUGA scan
Adequate organ function including: Cardiac ejection fraction at or above the institutional lower limit of normal, as assessed by either echocardiogram or multigated acquisition (MUGA) scan; ANC ≥ 1.0 x 10^9/L (may have received growth factor); Platelets ≥ 100 x 10^9/L; Hemoglobin ≥ 9 g/dL (may have been transfused); Total serum bilirubin ≤ 1.5 x ULN; AST/ALT ≤ 2.5 x ULN (or ≤ 5 x ULN if liver metastases are present); Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 50 mL/min as calculated using the Cockcroft-Gault (CG) equation; PT/INR ≤ 1.5 x ULN; Amylase ≤ 1 x ULN testing is only required in patients with a history of pancreatic disorders (Abnormality not of pancreatic origin is allowed); Participants with treated and controlled hypo or hyperthyroidism are eligible.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- O'Neal Comprehensive Cancer Center · Birmingham, Alabama
- University of California, San Francisco · San Francisco, California
- Georgetown University · Washington D.C., District of Columbia
- University of Chicago Medicine Comprehensive Cancer Center · Evergreen Park, Illinois
- Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University · Baltimore, Maryland
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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