Cisplatin + Veliparib for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of drugs for certain types of breast cancer. Researchers aim to determine if adding veliparib, which prevents cancer cells from repairing themselves, enhances the effectiveness of the chemotherapy drug cisplatin (also known as Platinol). The trial focuses on patients with triple-negative breast cancer or a BRCA mutation, particularly if the cancer has recurred or spread to the brain. Individuals with these specific types of breast cancer are encouraged to consider participation. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer therapy.
Do I have to stop taking my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you must not have received chemotherapy within 14 days or any immunotherapy, biologic, or investigational drug within 28 days before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that using cisplatin with veliparib may help treat certain types of breast cancer. Veliparib is a drug that prevents cancer cells from repairing themselves. Studies have found that combining veliparib with cisplatin can effectively combat cancer.
Regarding safety, earlier studies have not identified a maximum safe dose of veliparib, suggesting it is generally well-tolerated. However, some patients experienced side effects such as low white blood cells (increasing infection risk), low red blood cells (anemia), and low platelets (important for clotting). These side effects were more severe for a smaller group of patients.
Overall, the combination is considered safe for most people, allowing them to handle the treatment without major issues. Prospective trial participants should consult a healthcare provider about possible side effects to understand what to expect.12345Why do researchers think this study treatment might be promising for breast cancer?
Researchers are excited about the combination of cisplatin and veliparib for breast cancer because it targets the cancer in a unique way. While standard treatments often focus on chemotherapy alone, this approach combines cisplatin, a powerful chemotherapy drug, with veliparib, a PARP inhibitor that helps prevent cancer cells from repairing their DNA. This combination aims to enhance the effectiveness of the treatment by making it harder for cancer cells to survive and multiply. Additionally, this method could potentially offer better outcomes for patients by exploiting vulnerabilities in the cancer's DNA repair mechanisms.
What evidence suggests that this trial's treatments could be effective for breast cancer?
In this trial, participants will receive either a combination of veliparib and cisplatin or cisplatin with a placebo. Research has shown that combining veliparib with cisplatin can lead to better outcomes for patients with BRCA-like metastatic triple-negative breast cancer. One study demonstrated that this combination allowed patients to live 5.9 months without cancer progression, compared to 4.2 months with cisplatin alone. Another study found that 35% of patients responded well to the treatment, with some experiencing complete or partial tumor shrinkage. Additionally, adding veliparib may extend survival for patients with advanced triple-negative breast cancer after starting treatment. These findings suggest that veliparib could enhance the effectiveness of cisplatin in certain breast cancer cases.26789
Who Is on the Research Team?
Eve T Rodler
Principal Investigator
SWOG Cancer Research Network
Are You a Good Fit for This Trial?
This trial is for adults with recurrent or metastatic triple-negative breast cancer and/or BRCA mutation-associated breast cancer, which may include brain metastases. Participants must not be pregnant or nursing, agree to use contraception, have adequate organ function and no history of certain cancers or uncontrolled illnesses. Prior treatments must meet specific criteria.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cisplatin with or without veliparib. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion.
Long-term Follow-up
Participants are monitored every 18 weeks until progression, and then every 6 months for up to 5 years.
What Are the Treatments Tested in This Trial?
Interventions
- Cisplatin
- Veliparib
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor