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NCT01351909Active, not recruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 10 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
35 (actual)
First submitted
10 May 2011
Start date
2 May 2011
Primary completion date
25 Nov 2016
Lead sponsor
National Cancer Institute (NCI)
NCT number
NCT01351909

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 35
  • From 2 May 2011 to the primary completion date, 25 Nov 2016
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have radiotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to systemic agents administered more than 3 weeks earlier
  • Patients may not be receiving any other investigational agents
  • Patients with known brain metastases with active symptoms or requiring anticonvulsive medications, or steroids should be excluded from this clinical trial
  • Evidence of complete or partial bowel obstruction or other unable to take oral medications
  • Pregnant (positive pregnancy test) or lactating women will be excluded from the study; also, unwillingness to use effective means of contraception in subjects with child-bearing potential will be excluded from the study; women of child-bearing potential must use two forms of contraception (i.e., barrier contraception and one other method of contraception) at least 4 weeks prior to study entry, for the duration of study participation
  • Patients with active severe infection; known infection with human immunodeficiency virus (HIV), hepatitis B virus, hepatitis C virus, or severe concurrent illness will be excluded from the study; HIV-positive patients on combination antiretroviral therapy are ineligible
  • Prior treatment with veliparib (ABT-888) or other PARP inhibitors (e.g., olaparib)

Other illness

  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to veliparib (ABT-888) or cyclophosphamide used in the study
  • Patients with malabsorption syndrome or other condition that would interfere with intestinal absorption
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients with a history of seizure disorder requiring antiepileptics who have had a seizure episode within the last 6 months

Other

  • Patients unable to swallow whole capsules

Who the study is looking for

  • 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)
  • 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
  • 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
  • Measurable disease (Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1) or non-measurable disease, with measurement obtained within 4 weeks of registration
  • 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
  • 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
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (Karnofsky \>= 60%)
  • Leukocytes \>= 3,000/mcL
  • Absolute neutrophil count \>= 1,500/mcL
  • Platelets \>= 100,000/mcL
  • Hemoglobin \>= 9 g/dl (per manufacturer recommendation)
  • Total bilirubin within normal institutional limits (unless isolated indirect hyperbilirubinemia due to Gilbert's disease)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 × institutional upper limit of normal
  • Creatinine within normal institutional limits OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
  • Patients with a history of brain metastases are eligible if they have been treated with radiation and have stable brain metastases at least 3 months after radiation and must also be off steroids
  • Patients must be able to swallow whole capsules and tolerate oral medications
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; being not of childbearing potential is defined as: (1) prior hysterectomy, or (2) no menstrual period for at least 24 months; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Ability to understand and the willingness to sign a written informed consent document

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Montefiore Medical Center-Weiler Hospital
Coordinator of this site? Confirm its status
The BronxUnited StatesUnknown status
Montefiore Medical Center-Einstein Campus
Coordinator of this site? Confirm its status
The BronxUnited StatesUnknown status
Montefiore Medical Center - Moses Campus
Coordinator of this site? Confirm its status
The BronxUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.