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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 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.

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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.

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

FieldValue
Enrollment Target 58 participants
Start Date 2011-08-15
Est. Completion 2023-11-07
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT01349959

The ClinicalTrials.gov registry entry for NCT01349959 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 288-participant average among 29 other Recurrent Breast Carcinoma trials with a reported enrollment target (80% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

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 reports 7 study locations spanning 4 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.