Phase I Trial of Low-Dose Cyclophosphamide in Combination With Veliparib (ABT-888) in HER2/Neu-Negative Metastatic Breast Cancer

NCT: NCT01351909 · Status: ACTIVE NOT RECRUITING · Phase: Phase 1 · Sponsor: National Cancer Institute (NCI) · Started: 2011-05-02 · Est. Completion: 2027-03-31

Official 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.

Study Design

Study Type: INTERVENTIONAL
Allocation: NA
Model: SINGLE_GROUP
Masking: NONE
Enrollment: 35 participants

Interventions

DRUG: Cyclophosphamide — Given PO
OTHER: Laboratory Biomarker Analysis — Correlative studies
DRUG: Veliparib — Given PO

Primary Outcomes

Recommended phase II dose of veliparib and cyclophosphamide (21 days)

Secondary Outcomes

Clinical response (complete or partial response) according to RECIST version 1.1 (Up to 24 weeks)
Overall survival (Time from treatment initiation to death, assessed up to 6 years)
MacroH2A1.1 expression levels (Up to 6 years)
PARP1 expression status (Up to 6 years)

Trial Locations

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States
Montefiore Medical Center-Einstein Campus, The Bronx, New York, United States
Montefiore Medical Center-Weiler Hospital, The Bronx, New York, United States
Montefiore Medical Center - Moses Campus, The Bronx, New York, United States

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AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.