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NCT03101748 · ClinicalTrials.gov registry record · Phase 1
Neratinib and Paclitaxel With or Without Pertuzumab and Trastuzumab Before Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Breast Cancer
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT03101748: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT03101748 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 34 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03101748, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effect and best dose of neratinib and to see how well it works with paclitaxel and with or without pertuzumab and trastuzumab before combination chemotherapy in treating patients with breast cancer that has spread to other places in the body (metastatic). Neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with pertuzumab and trastuzumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as paclitaxel, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving neratinib, pertuzumab, trastuzumab, paclitaxel and combination chemotherapy may work better in treating patients with breast cancer.
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- OTHER Laboratory Biomarker Analysis
- DRUG Neratinib
- DRUG Paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2018-02-19 |
| Est. Completion | 2025-05-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03101748
The ClinicalTrials.gov registry entry for NCT03101748 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03101748 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03101748 about?
NCT03101748 is a clinical study titled "Neratinib and Paclitaxel With or Without Pertuzumab and Trastuzumab Before Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Breast Cancer". This phase I/II trial studies the side effect and best dose of neratinib and to see how well it works with paclitaxel and with or without pertuzumab and trastuzumab before combination chemotherapy in treating patients with breast cancer that has spread to other places in the body (metastatic). Nerat...
What is the current status of trial NCT03101748?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2018-02-19. Estimated completion is 2025-05-13.
What interventions are being tested in trial NCT03101748?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Laboratory Biomarker Analysis (OTHER), Neratinib (DRUG), Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT03101748?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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