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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site contacts updated at 1 of 3 sitesv12
  2. 2 versions Re-verified since Feb 16, 2026, no change to tracked fieldsv10-v11
  3. Site details revised at 1 of 3 sitesv9
  4. Site contacts updated at 1 of 3 sitesv8
  5. Site details revised at 2 of 3 sitesv7
Show 5 earlier versionsHide 5 earlier versions
  1. Site details revised at 2 of 3 sitesv6
  2. Study sites: 1 to 3v5
  3. 2 versions Re-verified since Feb 6, 2024, no change to tracked fieldsv3-v4
  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jan 1, 2023 to Jan 12, 2023 · Study title expanded, about 9 wordsv2 Show 3 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 1, 2023 to Jan 12, 2023
    • Study title expanded, about 9 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05660083
Lead Sponsor The Methodist Hospital Research Institute
Collaborators: Novartis Pharmaceuticals
Conditions HER2-negative Breast Cancer, Metastatic Breast Cancer, Metaplastic Breast Carcinoma, TNBC - Triple-Negative Breast Cancer
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov