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NCT01251874 · ClinicalTrials.gov registry record · Phase 1
Veliparib and Carboplatin in Treating Patients With HER2-Negative Metastatic Breast Cancer
A Phase 1 study of Recurrent Breast Carcinoma and Triple-Negative Breast Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
- 3
- Study locations
NCT01251874: Active Phase 1 study of Recurrent Breast Carcinoma and Triple-Negative Breast Carcinoma, sponsored by National Cancer Institute (NCI).
NCT01251874 is a Phase 1 study of Recurrent Breast Carcinoma and Triple-Negative Breast Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 44 participants, below the 289-participant average among 29 other Recurrent Breast Carcinoma trials with a reported enrollment target (85% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01251874, a Phase 1 study of Recurrent Breast Carcinoma and Triple-Negative Breast Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase I trial studies the side effects and best dose of veliparib when given together with carboplatin and to see how well they work in treating patients with human epidermal growth factor 2 (HER2)-negative breast cancer that has spread to other parts of the body. Carboplatin kills cancer cells by damaging the deoxyribonucleic acid (DNA) that lets the cancer cell survive and reproduce. The body has proteins that try to repair the damaged DNA. Veliparib may prevent these proteins from repairing the DNA so that carboplatin may be able to kill more tumor cells. Giving veliparib with carboplatin may kill more tumor cells than carboplatin alone.
Primary Outcome
Number and severity of toxicity incidents will be tabulated. Non-hematologic toxicities will be evaluated via the ordinal Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 standard toxicity grading. Hematologic toxicity measures of thrombocytopenia, neutropenia and leukopenia will be assessed using continuous variables as the outcome measures (primarily nadir and percent change from baseline values) as well as categorization via CTCAE standard toxicity grading. Frequency distrib
Conditions Studied
Interventions
- DRUG Carboplatin
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- OTHER Fluorothymidine F-18
Study Locations (3)
New York
- Montefiore Medical Center-Einstein Campus - The Bronx
- Montefiore Medical Center - Moses Campus - The Bronx
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2010-11-22 |
| Est. Completion | 2026-11-19 |
| Phase | Phase 1 |
What the registry record for NCT01251874 still lists
NCT01251874 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 289-participant average among 29 other Recurrent Breast Carcinoma trials with a reported enrollment target (85% lower).
The record links to 5 conditions, with Recurrent Breast Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT01251874 reports a single indexed study location in New York, Ohio.
Frequently Asked Questions
What is clinical trial NCT01251874 about?
NCT01251874 is a clinical study titled "Veliparib and Carboplatin in Treating Patients With HER2-Negative Metastatic Breast Cancer". This phase I trial studies the side effects and best dose of veliparib when given together with carboplatin and to see how well they work in treating patients with human epidermal growth factor 2 (HER2)-negative breast cancer that has spread to other parts of the body. Carboplatin kills cancer cells...
What is the current status of trial NCT01251874?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2010-11-22. Estimated completion is 2026-11-19.
What conditions does trial NCT01251874 study?
This clinical trial studies the following conditions: Recurrent Breast Carcinoma, Triple-Negative Breast Carcinoma, Stage IV Breast Cancer AJCC v6 and v7, Stage IIIC Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7.
What interventions are being tested in trial NCT01251874?
The interventions under investigation include: Carboplatin (DRUG), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Fluorothymidine F-18 (OTHER).
Who is sponsoring clinical trial NCT01251874?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01251874 being conducted?
This trial has 3 study locations across New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Breast Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01251874's enrollment target sits among peer trials
44 14th of 29 higher than 16 of 29 other Recurrent Breast Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Breast Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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