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Alkylating agent
Chemotherapy + Veliparib for Breast Cancer
Phase 3
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 8 years from randomization
Awards & highlights
Study Summary
This trial is testing whether adding veliparib to carboplatin and paclitaxel can help people with BRCA1/2 mutations and HER2-negative breast cancer live longer without their disease progressing.
Who is the study for?
This trial is for adults with HER2-negative breast cancer that's either spread or can't be removed by surgery. They must have a BRCA1 or BRCA2 mutation, an ECOG performance status of 0-2, and good organ function. People with active brain metastases, severe allergies to certain drugs, previous treatment with PARP inhibitors, more than two chemotherapy treatments for metastatic disease, or recent platinum therapy failure are excluded.Check my eligibility
What is being tested?
The study tests if adding Veliparib to the chemo drugs Carboplatin and Paclitaxel improves outcomes compared to placebo plus chemo in patients with specific genetic mutations in their tumors. It measures how long patients live without their cancer getting worse (PFS), overall survival (OS), clinical benefit rate (CBR), response rate (ORR) and PFS after subsequent therapies.See study design
What are the potential side effects?
Veliparib combined with Carboplatin and Paclitaxel may cause side effects like nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, hair loss, nerve damage causing numbness or tingling sensations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 8 years from randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 8 years from randomization
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 (CBR)
Objective Response Rate (ORR)
Overall Survival (OS)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Veliparib with Carboplatin and PaclitaxelExperimental Treatment3 Interventions
Veliparib capsules (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.
Group II: Veliparib Placebo with Carboplatin and PaclitaxelActive Control3 Interventions
Placebo capsules for veliparib (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Veliparib
2012
Completed Phase 3
~4820
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
967 Previous Clinical Trials
503,047 Total Patients Enrolled
7 Trials studying Breast Cancer
454 Patients Enrolled for Breast Cancer
ABBVIE INC.Study DirectorAbbVie
404 Previous Clinical Trials
147,581 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken PARP inhibitors before.You have had an allergic reaction to certain drugs or ingredients used in the study.You have cancer that has spread to your brain or spinal fluid.You have already tried more than two types of chemotherapy for advanced cancer.Your breast cancer has come back within a year after finishing platinum treatment, or you have already had more than one round of platinum treatment for your breast cancer.You have a visible tumor on a recent CT scan that can be measured and evaluated according to specific guidelines.You have a harmful mutation in the BRCA1 or BRCA2 genes.You should be able to perform daily activities without being restricted by your health issues, with some restrictions on physically strenuous activities.You have breast cancer that has spread or is too advanced for surgery or radiation to cure.Your breast cancer does not have a specific protein called Human Epidermal Growth Factor Receptor 2 (HER2).Your blood, kidney, and liver functions are normal within the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Veliparib Placebo with Carboplatin and Paclitaxel
- Group 2: Veliparib with Carboplatin and Paclitaxel
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
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