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Alkylating agents
Cisplatin + Veliparib for Breast Cancer
Phase 2
Waitlist Available
Led By Eve T Rodler
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must also meet at least one of the following criteria: Triple negative: histologically confirmed primary and/or metastatic site that is estrogen receptor (ER)-negative (=< 1%), progesterone receptor (PR)-negative (=< 1%), and HER2-negative; BRCA mutation: previously confirmed deleterious breast cancer 1, early onset (BRCA1) or breast cancer 2, early onset (BRCA2) germline mutation or suspected deleterious BRCA1 or BRCA2 germline mutation if the classification being used is the 5-tier classification; documentation of germline test results are required
Patients must be able to swallow whole capsules
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing cisplatin with or without veliparib to treat patients with triple-negative breast cancer and/or BRCA mutation-associated breast cancer.
Who is the study for?
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.Check my eligibility
What is being tested?
The effectiveness of cisplatin chemotherapy with or without the addition of veliparib (a PARP inhibitor) is being tested in patients. The study aims to determine if preventing tumor cells from repairing DNA mutations using veliparib enhances treatment outcomes compared to cisplatin alone.See study design
What are the potential side effects?
Potential side effects include those common to chemotherapy such as nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts; and for veliparib specifically: digestive issues, taste changes, low blood cell counts leading to anemia or bleeding risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Participants must have breast cancer that is negative for estrogen receptor (ER), progesterone receptor (PR), and HER2, or have a known harmful BRCA1 or BRCA2 gene mutation.
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I can swallow pills without any issues.
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My breast cancer has spread, and it is not HER2 positive according to tests.
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I am 18 years old or older.
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I can take care of myself and am up and about more than 50% of my waking hours.
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My liver tests are within the required range.
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I have brain metastases and meet specific health criteria.
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I had a full medical check-up in the last 28 days.
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I have not had any other cancer types, except for certain allowed cases.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Clinical benefit rate
Overall survival (OS)
Response rate (measurable disease only)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (cisplatin and veliparib)Experimental Treatment3 Interventions
Patients receive cisplatin IV over 1 hour on day 1 and veliparib PO BID on days 1-14. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (cisplatin and placebo)Active Control3 Interventions
Patients receive cisplatin IV over 1 hour on day 1 and placebo PO BID on days 1-14. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Veliparib
2012
Completed Phase 3
~4820
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,820 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Eve T RodlerPrincipal InvestigatorSWOG Cancer Research Network
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cisplatin or PARP inhibitors, but carboplatin over a year ago is okay.I have not had chemotherapy in the last 14 days.I do not have leukemia or myelodysplastic syndrome related to previous treatments.I haven't taken any immunotherapy, biologic, or experimental drugs in the last 28 days, nor bevacizumab in the last 42 days.I have not had a bone marrow or cord blood transplant from a donor.I do not have any uncontrolled illnesses that could interfere with the study.Participants must have breast cancer that is negative for estrogen receptor (ER), progesterone receptor (PR), and HER2, or have a known harmful BRCA1 or BRCA2 gene mutation.Your blood needs to have a certain amount of white blood cells, red blood cells, and platelets.I can swallow pills without any issues.I do not have severe numbness or pain in my hands or feet.I can take care of myself and am up and about more than 50% of my waking hours.My breast cancer has spread, and it is not HER2 positive according to tests.I have had the required scans to check my cancer within the last month.I am 18 years old or older.I agree to provide tissue samples for DNA testing and research.I have not had any other cancer types, except for certain allowed cases.I have had one or no chemotherapy treatments for my metastatic disease.I started taking bisphosphonates or denosumab at least a week before joining the study.I finished any radiation or hormonal therapy over 2 weeks ago.I have recovered from major side effects of cancer treatment, except for mild nerve issues.My liver tests are within the required range.My kidney function is normal, based on a recent test.I have had blood tests for my kidney function within the last 3 weeks.I haven't had a seizure in the last year.I have brain metastases and meet specific health criteria.I had a full medical check-up in the last 28 days.I am part of a group with worsening brain cancer spread.My hearing is mostly fine, with no major issues.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (cisplatin and veliparib)
- Group 2: Arm I (cisplatin and placebo)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there other drugs that have been studied alongside Cisplatin in the past?
"Cisplatin was first synthesized and studied in 1997 by City of Hope Comprehensive Cancer Center. However, it has since been the focus 1567 completed studies. Of these, 792 are active with a large portion being conducted out of Sandusky, Ohio."
Answered by AI
Has Cisplatin been cleared by the FDA for use?
"Cisplatin received a safety score of 2 from our team at Power. This is because, while there is some data supporting its safety, none of the existing data suggests that it is an effective treatment."
Answered by AI
What diseases or conditions is Cisplatin most often administered for?
"Cisplatin is often the go-to treatment for advanced ovarian cancer, but it can also be used to treat other conditions such as refractory to standard therapies, neoplasm metastasis, and advance directives."
Answered by AI
Are people currently being taken on as participants for this research?
"The clinicaltrials.gov website shows that this study is not recruiting patients at the moment, though this may change in the future. This particular trial was posted on July 7th, 2016 and updated November 1st, 2022. There are presently 7976 other studies looking for participants."
Answered by AI
How many individuals are test subjects in this experiment?
"This study is not currently enrolling new patients. The original posting was on July 7th, 2016 and the most recent update was November 1st, 2022. However, there are presently 7184 other clinical trials for carcinoma and 792 studies involving Cisplatin that are actively admitting participants."
Answered by AI
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