Cyclophosphamide + Veliparib for Advanced Breast Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you are on other investigational drugs or have not recovered from side effects of previous treatments. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug Cyclophosphamide + Veliparib for advanced breast cancer?
Is Cyclophosphamide safe for use in humans?
Cyclophosphamide, also known as Cytoxan or Neosar, has been used in various cancer treatments and is generally considered safe, but it can cause side effects like low blood cell counts and nausea. In some studies, it has been associated with less heart-related side effects compared to other drugs.36789
How is the drug combination of Cyclophosphamide and Veliparib unique for advanced breast cancer?
The combination of Cyclophosphamide and Veliparib is unique because it includes Veliparib, a PARP inhibitor (a drug that blocks an enzyme involved in repairing DNA damage in cells), which may enhance the effectiveness of Cyclophosphamide, especially in patients with advanced breast cancer that is resistant to other treatments.35101112
What is the purpose of this trial?
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.
Research Team
Joseph Sparano, MD
Principal Investigator
Montefiore Medical Center - Moses Campus
Eligibility Criteria
This trial is for adults with advanced or metastatic HER2/neu negative breast cancer who've had prior chemotherapy. They must have a certain level of blood cells, no severe liver/kidney issues, and be able to take oral meds. Pregnant women, those unable to use contraception, or patients with recent seizures or bowel obstructions can't join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive veliparib and cyclophosphamide orally once daily on days 1-21, with courses repeating every 21 days in the absence of disease progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cyclophosphamide
- Veliparib
Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor