Cyclophosphamide and Veliparib in Treating Patients With Locally Advanced or Metastatic Breast Cancer (NCT01351909)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Phase I: Patients must have histologically confirmed breast cancer (metastatic breast cancer \[MBC\]) that is human epidermal growth factor receptor 2 (HER2/neu) negative (as determined by local pathology or reference laboratory), and have disease that is metastatic (stage IV \[TxNxM1\]) or locally advanced and not amenable to potentially curative surgical resection (eg, clinical stage IIIB-C)
2. HER2/neu negative disease (performed on primary tumor and/or metastatic lesion using commercially available/approved assay in local institutional or reference laboratory), according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
3. National Comprehensive Cancer Network (NCCN) guidelines recommend for metastatic breast cancer "…biopsy documentation of first recurrence, if possible, and determination of hormone receptor status (estrogen receptor \[ER\] and progesterone receptor \[PR\]) and HER2 status…."; therefore, histologic and/or cytologic confirmation of metastatic disease is encouraged whenever feasible, but not required; in some circumstances, histologic confirmation may not be feasible (eg, bone metastases not amenable to biopsy and elevated cancer antigen \[CA\]27-29 tumor marker); for patients who have had histologic confirmation of metastatic disease, it is required that the biopsy confirm that the metastatic tumor is ER and/or PR positive, and HER2/neu negative; for patients in whom biopsy confirmation of metastatic disease is not feasible, it is required that the primary tumor be ER and/or PR-positive and HER2/neu negative
4. Measurable disease (Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1) or non-measurable disease, with measurement obtained within 4 weeks of registration
5. Phase I: Patients must have received at least one prior chemotherapy regimen for metastatic disease; patients with deleterious germ line mutations in breast cancer (BRCA)1 or BRCA2 are not required to have received prior chemotherapy for metastatic disease
6. Patients must have had progressive disease after at least one line of endocrine therapy for metastatic disease (includes relapse while receiving endocrine therapy); there should be at least 1 week interval between the last endocrine treatment for an aromatase inhibitor and at least 2 weeks for tamoxifen or fulvestrant
7. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (Karnofsky \>= 60%)
8. Leukocytes \>= 3,000/mcL
9. Absolute neutrophil count \>= 1,500/mcL
10. Platelets \>= 100,000/mcL
11. Hemoglobin \>= 9 g/dl (per manufacturer recommendation)
12. Total bilirubin within normal institutional limits (unless isolated indirect hyperbilirubinemia due to Gilbert's disease)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (5 Sites)

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

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.