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Veliparib, Cisplatin, and Vinorelbine Ditartrate in Treating Patients With Recurrent and/or Metastatic Breast Cancer

NCT01104259 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-08-10

No results posted yet for this study

Summary

This phase I trial studies the side effects and best dose of veliparib when given together with cisplatin and vinorelbine ditartrate in treating patients with breast cancer that has returned or spread to other parts of the body. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and vinorelbine ditartrate, 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. Giving veliparib together with combination chemotherapy may be a better treatment for breast cancer.

Conditions

  • Estrogen Receptor-negative Breast Cancer
  • HER2-negative Breast Cancer
  • Hereditary Breast/Ovarian Cancer - BRCA1
  • Hereditary Breast/Ovarian Cancer - BRCA2
  • Male Breast Cancer
  • Progesterone Receptor-negative Breast Cancer
  • Recurrent Breast Cancer
  • Stage IV Breast Cancer
  • Triple-negative Breast Cancer

Interventions

DRUG

veliparib

Given PO

DRUG

cisplatin

Given IV

DRUG

vinorelbine tartrate

Given IV

OTHER

laboratory biomarker analysis

Correlative studies

OTHER

pharmacological study

Correlative studies

Sponsors & Collaborators

Principal Investigators

  • Jennifer Specht · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2015-02-28
Completion
2017-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT01104259 on ClinicalTrials.gov