Study on Alpelisib, iNOS Inhibitor, and Nab-paclitaxel for Patients with HER2 Negative Metaplastic Breast Cancer

Sponsor: The Methodist Hospital Research Institute

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05660083

Provider View

This clinical trial is testing a new combination of drugs, including alpelisib, nab-paclitaxel, and L-NMMA, to see if they are safe and effective for treating HER2 negative metaplastic breast cancer that has spread or is advanced and not responding to other treatments.

Patient Parameters

Program Overview

The study aims to find out if a combination of the drugs alpelisib, nab-paclitaxel, and L-NMMA can help treat HER2 negative metaplastic breast cancer that is advanced or has spread and hasn't responded to other treatments. Participants will receive these drugs every three weeks until the cancer progresses, side effects become too severe, or they choose to leave the study. Nab-paclitaxel is given through an IV on the first day of each three-week cycle, alpelisib is taken by mouth daily, and L-NMMA is given through an IV on the first five days of each cycle.

Description

This Phase II study is exploring a new treatment approach for HER2 negative metaplastic breast cancer (MpBC), a rare and difficult-to-treat form of breast cancer. The study will test the safety and effectiveness of combining an iNOS inhibitor and nab-paclitaxel with alpelisib. MpBC is known for being resistant to standard chemotherapy, and patients often have a poor prognosis. Researchers believe that targeting a specific enzyme, iNOS, which is linked to cancer growth and chemotherapy resistance, may improve treatment outcomes. The study will include patients who have not responded to previous treatments, including immunotherapy. Participants will receive the study drugs in cycles, with regular monitoring to assess the treatment's impact on their cancer.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Be at least 18 years old.
  • Have a confirmed diagnosis of HER2 negative metaplastic breast cancer or triple negative breast cancer with specific cell types.
  • Cancer must be advanced or have spread and be measurable by scans.
  • Have a performance status indicating they are fully active or have some restrictions but can still perform light work.
  • Have adequate organ and blood function based on specific lab tests.
  • Have controlled blood sugar levels.
  • Be able to swallow pills and take aspirin.
  • Women of childbearing age must use contraception during the study and for 90 days after the last treatment. Men must use condoms and not donate sperm during the study and for a specified time after.
  • Must have recovered from any major surgery before starting the study.
  • Willing to follow the study protocol, including attending all visits and undergoing all tests and treatments.

Exclusion Criteria

  • Cannot use certain medications that affect liver enzymes or blood clotting.
  • Cannot have received certain previous cancer treatments.
  • Cannot have a history of severe skin reactions or certain heart conditions.
  • Cannot have uncontrolled high blood pressure or certain heart problems.
  • Cannot be participating in another clinical trial or have used an investigational drug recently.
  • Cannot have allergies to any of the study drugs.
  • Cannot have another active cancer requiring treatment.
  • Cannot have certain lung diseases or psychiatric conditions that would interfere with the study.
  • Cannot have uncontrolled diabetes or certain digestive issues.
  • Cannot have untreated brain metastases or certain nerve problems.
  • Cannot be pregnant, breastfeeding, or planning to become pregnant during the study.

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