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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wyrażenie świadomej zgody na udział w badaniu.
  • Osoby w wieku 18 lat lub starsze.
  • Potwierdzony rak piersi HER2-ujemny z cechami raka płaskonabłonkowego lub mięsakowatego.
  • Zaawansowany lub przerzutowy rak piersi HER2-ujemny, który można zmierzyć.
  • Dobry ogólny stan zdrowia (według skali ECOG 0-1).
  • Wystarczająca ilość komórek krwi i prawidłowe wyniki badań wątroby i nerek.
  • Możliwość przyjmowania leków doustnie i aspiryny.
  • Kobiety w wieku rozrodczym muszą stosować antykoncepcję.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
June 4, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (3)

National Institute of Health Clinical Center

Bethesda, United States

Houston Methodist Neal Cancer Center

Houston, United States

The University of Texas MD Anderson Cancer Center

Houston, United States

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.

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