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Dinaciclib and Epirubicin Hydrochloride in Treating Patients With Metastatic Triple-Negative Breast Cancer

NCT01624441 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-03-30

No results posted yet for this study

Summary

This phase I clinical trial studies the side effects and the best dose of dinaciclib when given together with epirubicin hydrochloride (epirubicin) in patients with metastatic (cancer that has spread to other parts of the body) triple-negative breast cancer. Dinaciclib is designed to stop cancer cells from dividing into new cancer cells. Epirubicin is designed to block the way cancer cells grow and divide and may slow or stop cancer cells from spreading throughout the body. Researchers want to find out what is the highest tolerable dose of the experimental drug dinaciclib that can be given in combination with epirubicin in patients with metastatic triple negative breast cancer.

Conditions

  • Estrogen Receptor Negative
  • HER2/Neu Negative
  • Male Breast Carcinoma
  • Progesterone Receptor Negative
  • Recurrent Breast Carcinoma
  • Stage IV Breast Cancer AJCC v6 and v7
  • Triple-Negative Breast Carcinoma

Interventions

DRUG

Dinaciclib

Given IV

DRUG

Epirubicin Hydrochloride

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Stacy Moulder · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-21
Primary Completion
2013-09-10
Completion
2013-09-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01624441 on ClinicalTrials.gov