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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT05660083
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • L-NMMA — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 12, 2023
Status verified
Jun 2026
Primary completion
Dec 1, 2026
Completion
Dec 2, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: iNOS inhibitor and nab-paclitaxel in combination with alpelisib.
    iNOS inhibitor and nab-paclitaxel in combination with alpelisib in patients with HER2 negative, metastatic or locally advanced MpBC.

Primary Outcome Measure

Define recommended phase II dose (RP2D) [ Time Frame: The RP2D will be defined as the highest dose administered at which 6 patients complete treatment with experiencing <2 DLTs (Study completion is an average of 6 cycles, determined by diseases progression, unacceptable toxicity, physician's discretion) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
National Institute of Health Clinical CenterBethesdaMaryland20892
Stanley Lipkowitz, Principal Investigator, MD
[email protected]
240-541-4547
Houston Methodist Neal Cancer CenterHoustonTexas77030
Polly Niravath, MD
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Clinton Yam, Principal Investigator, MD, MS
[email protected]
713-792-2817

Find similar trials in Bethesda, MD

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
National Institute of Health Clinical Center· Bethesda, MDHouston Methodist Neal Cancer Center· Houston, TXThe University of Texas MD Anderson Cancer Center· Houston, TX

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