Alpelisib/iNOS Inhibitor/Nab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC) (NCT05660083)
Phase II Trial of Alpelisib With iNOS Inhibitor and Nab-paclitaxel in Patients With HER2 Negative Metastatic or Locally Advanced Metaplastic Breast Cancer (MpBC)
🩺 Plain-English Summary (8th-Grade Level)
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 be administered intravenously on Day 1 of the 3 week cycles. Participants will take the drug alpelisib by mouth once daily at a dose determined by a safety study and the drug L-NMMA will be given intravenously on days 1 to 5 of the 3 week cycles.
Who can join: Review the eligibility criteria below.
Location: National Institute of Health Clinical Center — Bethesda, Maryland
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (3 Sites)
- National Institute of Health Clinical Center — Bethesda, Maryland
- Houston Methodist Neal Cancer Center — Houston, Texas
- The University of Texas MD Anderson Cancer Center — Houston, Texas
📞 Contact the Study Coordinator
Phone: (346) 238-4814
Email: abrock@houstonmethodist.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in HER2-negative Breast Cancer
- CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer — Chicago, Illinois
- A Ph II Study of the TheraBionic P1 Device in Subjects With Hormone Positive Breast Cancer — Bay City, Michigan
- DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Breast Cancer Patients — Jacksonville, Florida
- Prospective Registry of ADC as First- and Second-line Treatment for Breast Cancer — San Francisco, California
Explore by condition: All HER2-negative Breast Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.