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

NCT05660083

This study is recruiting at 3 US sites in 2 states, according to its ClinicalTrials.gov record last updated .

Summary

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • HER2-negative Breast Cancer
  • Metastatic Breast Cancer
  • Metaplastic Breast Carcinoma
  • TNBC - Triple-Negative Breast Cancer

Eligibility basics and study details

Study type
Interventional
Phase
Phase 2
Ages
18 years and older
Sex
All
Healthy volunteers
Not accepted
Sponsor
The Methodist Hospital Research Institute
Last updated on ClinicalTrials.gov
June 4, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Maryland · 1

  • National Institute of Health Clinical Center · Bethesda, MD

Texas · 2

  • Houston Methodist Neal Cancer Center · Houston, TX
  • The University of Texas MD Anderson Cancer Center · Houston, TX

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.