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NCT05660083 · ClinicalTrials.gov registry record · Phase 2
Alpelisib/iNOS Inhibitor/Nab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC)
A Phase 2 study of Metastatic Breast Cancer and HER2-Negative Breast Cancer, sponsored by The Methodist Hospital Research Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 3
- Study locations
NCT05660083 is a Phase 2 study of Metastatic Breast Cancer and HER2-Negative Breast Cancer that is actively recruiting participants, run by The Methodist Hospital Research Institute. The registered enrollment target is 36 participants, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (82% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT05660083, a Phase 2 study of Metastatic Breast Cancer and HER2-Negative Breast Cancer, is actively recruiting participants, sponsored by The Methodist Hospital Research Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 3
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG L-NMMA
Study Locations (3)
Texas
- Houston Methodist Neal Cancer Center - Houston
- The University of Texas MD Anderson Cancer Center - Houston
Maryland
- National Institute of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2023-01-12 |
| Est. Completion | 2028-12-02 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05660083
The ClinicalTrials.gov registry entry for NCT05660083 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (82% lower). The listed sponsor is The Methodist Hospital Research Institute, which has 126 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which L-NMMA is the first listed.
NCT05660083 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Texas, Maryland.
Frequently Asked Questions
What is clinical trial NCT05660083 about?
NCT05660083 is a clinical study titled "Alpelisib/iNOS Inhibitor/Nab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC)". 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. Part...
What is the current status of trial NCT05660083?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2023-01-12. Estimated completion is 2028-12-02.
What conditions does trial NCT05660083 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer, HER2-Negative Breast Cancer, TNBC - Triple-Negative Breast Cancer, Metaplastic Breast Carcinoma.
What interventions are being tested in trial NCT05660083?
The interventions under investigation include: L-NMMA (DRUG).
Who is sponsoring clinical trial NCT05660083?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05660083 being conducted?
This trial has 3 study locations across Maryland, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.