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Cyclophosphamide and Veliparib in Treating Patients With Locally Advanced or Metastatic Breast Cancer

NCT01351909 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-04-13

No results posted yet for this study

Summary

This phase I trial studies the side effects and best dose of cyclophosphamide and veliparib when given together in treating patients with breast cancer that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Drugs used in chemotherapy, such as cyclophosphamide, 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. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cyclophosphamide together with veliparib may work better in treating breast cancer.

Conditions

  • Locally Advanced Unresectable Breast Carcinoma
  • Metastatic Breast Carcinoma
  • Recurrent Breast Carcinoma
  • Stage IIIB Breast Cancer AJCC v7
  • Stage IIIC Breast Cancer AJCC v7
  • Stage IV Breast Cancer AJCC v6 and v7

Interventions

DRUG

Cyclophosphamide

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Veliparib

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Joseph A Sparano · Montefiore Medical Center - Moses Campus

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-02
Primary Completion
2016-11-25
Completion
2027-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01351909 on ClinicalTrials.gov