Alpelisib/iNOS Inhibitor/Nab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC)

This is a research study to test the safety and effectiveness of using the drug alpelisib together with chemotherapy (nab-paclitaxel) and a drug called L-NMMA in patients with HER2 negative metastatic or locally advanced metaplastic breast cancer, who have not responded to previous treatments. Participants in this study in addition to the standard care chemotherapy will also receive the drug alpelisib and L-NMMA. The therapies will be administered every 3 weeks (1 cycle) until disease progression, toxicity or until the participant withdraws from the study. The nab-paclitaxel chemotherapy will

Trial Details

NCT ID
NCT05660083
Phase
PHASE2
Sponsor
The Methodist Hospital Research Institute
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • L-NMMA
Locations (sample)
  • Bethesda, Maryland, United States|38.98067,-77.10026
  • Houston, Texas, United States|29.76328,-95.36327
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • The patient (or legally acceptable representative if applicable) provides written informed consent for the study.
  • At least 18 years of age on the day of informed consent signing.
  • Histologically confirmed HER2 negative MpBC and/or Triple Negative Breast Cancer (TNBC) with squamous and/or sarcomatoid elements, including osseou…
  • HER2 negative status as defined by the current American Society of Clinical Oncology and College of American Pathologists guidelines at time of stu…

For full eligibility, visit ClinicalTrials.gov.

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