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

Recruiting Phase 2 Interventional Study
HER2-negative Breast Cancer Metastatic Breast Cancer Metaplastic Breast Carcinoma TNBC - Triple-Negative Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
36 (estimated)
Sponsor
The Methodist Hospital Research Institute · Other
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About This Trial
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 alpe…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. The patient (or legally acceptable representative if applicable) provides written informed consent for the study. 2. At least 18 years of age on the day of informed consent signing. 3. Histologically confirmed HER2 negative MpBC and/or Triple Negative Breast Cancer (TNBC) wit…
Contacts

Alexys Brock

346-238-4814

abrock@houstonmethodist.org

CONTACT

Titilayo Olubajo

713-363-9803

tolubajo@houstonmethodist.org

CONTACT