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NCT01351909 · ClinicalTrials.gov registry record · Phase 1
Cyclophosphamide and Veliparib in Treating Patients With Locally Advanced or Metastatic Breast Cancer
A Phase 1 study of Metastatic Breast Carcinoma and Recurrent Breast Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 5
- Study locations
NCT01351909: Active Phase 1 study of Metastatic Breast Carcinoma and Recurrent Breast Carcinoma, sponsored by National Cancer Institute (NCI).
NCT01351909 is a Phase 1 study of Metastatic Breast Carcinoma and Recurrent Breast Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 35 participants, below the 164-participant average among 32 other Metastatic Breast Carcinoma trials with a reported enrollment target (79% lower). The trial reports 5 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01351909, a Phase 1 study of Metastatic Breast Carcinoma and Recurrent Breast Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 5
- Study locations
Study Summary
This phase I trial studies the side effects and best dose of cyclophosphamide and veliparib when given together in treating patients with breast cancer that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Drugs used in chemotherapy, such as 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. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cyclophosphamide together with veliparib may work better in treating breast cancer.
Primary Outcome
The descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 will be utilized for adverse events reporting.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- OTHER Laboratory Biomarker Analysis
- DRUG Veliparib
Study Locations (5)
New York
- Laura and Isaac Perlmutter Cancer Center at NYU Langone - New York
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center - New York
- Montefiore Medical Center-Einstein Campus - The Bronx
- Montefiore Medical Center-Weiler Hospital - The Bronx
- Montefiore Medical Center - Moses Campus - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2011-05-02 |
| Est. Completion | 2026-03-18 |
| Phase | Phase 1 |
What the registry record for NCT01351909 still lists
NCT01351909 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 164-participant average among 32 other Metastatic Breast Carcinoma trials with a reported enrollment target (79% lower).
The record links to 6 conditions, with Metastatic Breast Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT01351909 lists 5 locations in 1 state (New York).
Frequently Asked Questions
What is clinical trial NCT01351909 about?
NCT01351909 is a clinical study titled "Cyclophosphamide and Veliparib in Treating Patients With Locally Advanced or Metastatic Breast Cancer". This phase I trial studies the side effects and best dose of cyclophosphamide and veliparib when given together in treating patients with breast cancer that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Drugs used in chemotherapy, such as cyclophosp...
What is the current status of trial NCT01351909?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2011-05-02. Estimated completion is 2026-03-18.
What conditions does trial NCT01351909 study?
This clinical trial studies the following conditions: Metastatic Breast Carcinoma, Recurrent 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 NCT01351909?
The interventions under investigation include: Cyclophosphamide (DRUG), Laboratory Biomarker Analysis (OTHER), Veliparib (DRUG).
Who is sponsoring clinical trial NCT01351909?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01351909 being conducted?
This trial has 5 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic 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 NCT01351909's enrollment target sits among peer trials
35 20th of 32 higher than 12 of 32 other Metastatic Breast Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic 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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