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NCT01349959 · ClinicalTrials.gov registry record · Phase 2
Azacitidine and Entinostat in Treating Patients With Advanced Breast Cancer
A Phase 2 study of Recurrent Breast Carcinoma and Triple-Negative Breast Carcinoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
- 7
- Study locations
NCT01349959: Completed Phase 2 study of Recurrent Breast Carcinoma and Triple-Negative Breast Carcinoma, sponsored by National Cancer Institute (NCI).
NCT01349959 is a Phase 2 study of Recurrent Breast Carcinoma and Triple-Negative Breast Carcinoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 58 participants, below the 288-participant average among 29 other Recurrent Breast Carcinoma trials with a reported enrollment target (80% lower). The trial reports 7 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01349959, a Phase 2 study of Recurrent Breast Carcinoma and Triple-Negative Breast Carcinoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
- 7
- Study locations
Study Summary
This phase II trial studies how well giving azacitidine and entinostat work in treating patients with advanced breast cancer. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving azacitidine together with entinostat may kill more tumor cells.
Primary Outcome
Percentage of participants with complete or partial response will be estimated independently for each cohort by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Conditions Studied
Interventions
- DRUG Azacitidine
- OTHER Laboratory Biomarker Analysis
- DRUG Entinostat
- OTHER Pharmacological Study
Study Locations (7)
California
- City of Hope Comprehensive Cancer Center - Duarte
- USC / Norris Comprehensive Cancer Center - Los Angeles
- University of California Davis Comprehensive Cancer Center - Sacramento
Minnesota
- Unity Hospital - Fridley
- Metro Minnesota Community Oncology Research Consortium - Saint Louis Park
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
Pennsylvania
- University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2011-08-15 |
| Est. Completion | 2023-11-07 |
| Phase | Phase 2 |
What the finished NCT01349959 record still lists
NCT01349959 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 288-participant average among 29 other Recurrent Breast Carcinoma trials with a reported enrollment target (80% lower).
The record links to 5 conditions, with Recurrent Breast Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Azacitidine is the first listed.
NCT01349959 lists 7 locations in 4 states (California, Minnesota, Maryland).
Frequently Asked Questions
What is clinical trial NCT01349959 about?
NCT01349959 is a clinical study titled "Azacitidine and Entinostat in Treating Patients With Advanced Breast Cancer". This phase II trial studies how well giving azacitidine and entinostat work in treating patients with advanced breast cancer. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Enti...
What is the current status of trial NCT01349959?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2011-08-15. Estimated completion is 2023-11-07.
What conditions does trial NCT01349959 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, Male Breast Carcinoma.
What interventions are being tested in trial NCT01349959?
The interventions under investigation include: Azacitidine (DRUG), Laboratory Biomarker Analysis (OTHER), Entinostat (DRUG), Pharmacological Study (OTHER).
Who is sponsoring clinical trial NCT01349959?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01349959 being conducted?
This trial has 7 study locations across California, Maryland, Minnesota, Pennsylvania. 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 NCT01349959's enrollment target sits among peer trials
58 12th of 29 higher than 18 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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