Actively Recruiting
Alpelisib/iNOS Inhibitor/Nab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC)
Led by The Methodist Hospital Research Institute · Updated on 2026-04-03
36
Participants Needed
3
Research Sites
307 weeks
Total Duration
On this page
Sponsors
T
The Methodist Hospital Research Institute
Lead Sponsor
N
Novartis Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Alpelisib/iNOS Inhibitor/Nab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent for the study
- Be at least 18 years old at time of consent
- Have histologically confirmed HER2 negative metaplastic breast cancer or triple negative breast cancer with squamous and/or sarcomatoid elements
- Have HER2 negative status as defined by current clinical guidelines
- Have locally advanced inoperable or metastatic metaplastic breast cancer with measurable disease
- Have Eastern Cooperative Oncology Group performance status of 0 or 1
- Have adequate organ and marrow function including hemoglobin 69.0 g/dl, neutrophil count 61000/bcL, platelet count 6100,000/bcL, bilirubin 61.5 x institutional upper limit of normal, liver enzymes 65 x institutional upper limit of normal, and creatinine 61.5 x upper limit of normal or creatinine clearance 60 mL/min
- Have fasting blood glucose 6140 mg/dl and hemoglobin A1c 67.0
- Be able to swallow oral medication
- Be able to take aspirin
- Women of childbearing potential must agree to use contraception during the study and 90 days after last dose
- Men must use condoms during the study and avoid sperm donation
- Have recovered adequately from any major surgery before starting treatment
- Be willing and able to comply with the study protocol throughout the trial
You will not qualify if you...
- Use of strong cytochrome P450 3A4 inhibitors or inducers within 1 week before treatment
- Current use of warfarin or coumarin-derived anticoagulants
- Use of medications that interfere with nitrate/nitrite levels
- Previous treatment with nab-paclitaxel, PI3K inhibitors, AKT inhibitors, or mTOR inhibitors
- History of Stevens-Johnson syndrome or toxic epidermal necrolysis
- HIV positive status due to metabolism concerns
- Poorly controlled hypertension (systolic BP >150 mm Hg), but controlled hypertension on stable medication allowed
- Certain heart conditions including symptomatic congestive heart failure, cardiomyopathy, low left ventricular ejection fraction, recent heart attack, unstable angina, serious arrhythmias, pericarditis, congenital QT prolongation, or prolonged QT interval
- Participation in another investigational study within 3 weeks prior to treatment
- Known hypersensitivity to study drugs or their components
- Additional active malignancies requiring treatment
- Pneumonitis, interstitial lung disease, or moderate to severe chronic lung disease
- Psychiatric or substance abuse disorders interfering with study compliance
- Malabsorption syndromes or significant gastrointestinal surgery
- Untreated or symptomatic metastatic central nervous system disease
- Type I diabetes or uncontrolled type II diabetes (HbA1c >7%)
- Uncontrolled gastric ulcers
- Grade 2 or higher sensory neuropathy
- Osteonecrosis of the jaw
- Pancreatitis
- Pregnancy, breastfeeding, or planning pregnancy during the study and 30 days after last treatment dose
AI-Screening
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Trial Site Locations
Total: 3 locations
1
National Institute of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
2
Houston Methodist Neal Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
3
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Alexys Brock
CONTACT
T
Titilayo Olubajo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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