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.
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