RecruitingPhase 2NCT05660083

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

Phase II Trial of Alpelisib With iNOS Inhibitor and Nab-paclitaxel in Patients With HER2 Negative Metastatic or Locally Advanced Metaplastic Breast Cancer (MpBC)


Sponsor

The Methodist Hospital Research Institute

Enrollment

36 participants

Start Date

Jan 12, 2023

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a three-drug combination — alpelisib (a targeted therapy), an iNOS inhibitor (an experimental drug), and nab-paclitaxel (a chemotherapy) — in people with a rare and aggressive form of breast cancer called metaplastic breast cancer (MpBC) or triple-negative breast cancer (TNBC) that has spread or cannot be surgically removed. **You may be eligible if...** - You are 18 or older - You have been diagnosed with HER2-negative metaplastic breast cancer or triple-negative breast cancer with specific features (squamous, sarcomatoid, or similar elements) - Your cancer has spread or is locally advanced and cannot be operated on - You are in good health (ECOG 0–1) - Your blood counts, liver, and kidney function meet the study requirements - You may have had prior treatment, including immunotherapy **You may NOT be eligible if...** - Your cancer is HER2-positive - You do not have measurable disease on imaging - You have serious organ dysfunction or uncontrolled medical conditions - You are pregnant or breastfeeding - You have had certain prior treatments that conflict with the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGL-NMMA

Patients with HER2 negative metastatic or locally advanced MpBC, will receive a combination of an iNOS inhibitor, nab-paclitaxel and alpelisib . As prophylaxis against deep venous thrombosis and hypertension, patients will receive aspirin (81 mg po daily) and amlodipine (10 mg po Days 0-5 each cycle). Metformin will be initiated at 500 mg once daily starting one week prior to treatment to reduce risk of severe hyperglycemia. Based on tolerability and serial blood sugar assessments, metformin dose will be increased to 500 mg twice daily, followed by 500 mg with breakfast and 1000 mg with dinner, followed by further increase to 1000 mg twice daily if needed. Insulin sensitizers and/or SGLT2i will be used as second anti-diabetic agents, if necessary. For prophylaxis of alpelisib rash, patients will be treated with an anti-histamine (cetirizine 10 mg daily) along with alpelisib.


Locations(3)

National Institute of Health Clinical Center

Bethesda, Maryland, United States

Houston Methodist Neal Cancer Center

Houston, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

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NCT05660083


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