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COMPLETED Phase 2

Azacitidine and Entinostat in Treating Patients With Advanced Breast Cancer

NCT01349959 · View on ClinicalTrials.gov ↗

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)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01349959

The ClinicalTrials.gov registry entry for NCT01349959 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01349959 reports 7 study locations spanning 4 distinct geographic areas — top geographies include California, Minnesota, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01349959?

The interventions under investigation include: Azacitidine (DRUG), Laboratory Biomarker Analysis (OTHER), Entinostat (DRUG), Pharmacological Study (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01349959?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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