NCT01351909

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine the recommended phase II dose of veliparib (ABT-888) that can be combined with metronomic dose cyclophosphamide in patients with metastatic breast cancer. SECONDARY OBJECTIVES: I. To determine whether the macroH2A1.1 and poly (adenosine diphosphate \[ADP\]-ribose) polymerase 1 (PARP1) expression status in archival paraffin embedded tumor specimens from either the primary tumor or metastatic disease is predictive of clinical benefit with veliparib (ABT-888) plus cyclophosphamide. OUTLINE: This is a dose-escalation study. Patients receive veliparib orally (PO) once daily (QD) and cyclophosphamide PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.

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

Type	Name	Description
DRUG	Cyclophosphamide	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Veliparib	Given PO

Timeline

• Start date: 2011-05-02
• Primary completion: 2016-11-25
• Completion: 2027-03-31
• First posted: 2011-05-11
• Last updated: 2026-04-13

Locations

5 sites across 1 country: United States