Your session is about to expire
← Back to Search
PARP Inhibitor
ABT-888 + Temozolomide for BRCA-Mutated Breast Cancer
Phase 2
Waitlist Available
Led By Steven Isakoff, MD, PhD
Research Sponsored by Steven J Isakoff, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All immunohistochemical subtypes of breast cancer are eligible. HER2 positive breast cancer must have progressed on prior standard HER2 therapy or have a contraindication to anti-HER2 therapy
Patients must be progressing on their current therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is testing a combination of drugs to see if it's safe and effective in treating patients with metastatic breast cancer, specifically those with the BRCA mutation.
Who is the study for?
This trial is for adults with metastatic or advanced recurrent breast cancer that's not treatable by standard methods. It's specifically recruiting those with BRCA mutations, who've had prior chemotherapy but no combination of PARP inhibitors and chemo. Participants should have a life expectancy over 12 weeks, stable brain metastases if present, and agree to contraception.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of ABT-888 (a PARP inhibitor) combined with temozolomide (chemotherapy). The goal is to see if this combo can better kill cancer cells in patients with BRCA mutation-related breast cancer by preventing the cells from repairing their DNA damage.See study design
What are the potential side effects?
Possible side effects include nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems, hair loss, constipation or diarrhea. There may also be specific reactions related to ABT-888 like allergic responses or liver function changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer has worsened despite HER2 therapy or I can't have HER2 treatment.
Select...
My current cancer treatment is not working.
Select...
My breast cancer is advanced, cannot be surgically removed, and standard treatments are not effective.
Select...
I am 18 years old or older.
Select...
I have had at least one chemotherapy treatment for my cancer after it spread.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine Safety and Efficacy in an Expansion Cohort of BRCA1/2 Mutation Carriers.
To determine the objective response rate (ORR) of ABT-888 and temozolomide (TMZ) in metastatic breast cancer.
Secondary outcome measures
To evaluate progression free survival.
To evaluate the clinical benefit rate.
To further characterize the safety and tolerability of ABT-888 and TMZ in patients with metastatic breast cancer.
Side effects data
From 2013 Phase 2 trial • 75 Patients • NCT0105159653%
Thrombocytopenia
48%
Nausea
47%
Anemia
25%
Fatigue
20%
Leucopenia
19%
Vomiting
17%
Neutropenia
12%
Anorexia
7%
Diarrhea
4%
Pain NOS
4%
Neuropathy: sensory
3%
Shortness of breath
3%
Lymphopenia
3%
Dizziness
3%
Fever
3%
Constipation
1%
Cough
1%
Peeling of feet
1%
Febrile neutropenia
1%
Urinary Hemorrhage
1%
Elevated creatinine
1%
Hypoalbuminemia
1%
Weight loss
1%
Rash
1%
Vaginal hemorrhage
1%
Alopecia
1%
Edema: limb
1%
Headache
1%
Petechiae/Purpura
1%
Ascites
1%
Dysphagia
1%
Dysgeusia
1%
Dehydration
100%
80%
60%
40%
20%
0%
Study treatment Arm
ABT-888 and Temozolomide
Trial Design
1Treatment groups
Experimental Treatment
Group I: TMZ/ABT888Experimental Treatment2 Interventions
Combination therapy with temozolomide and veliparib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
FDA approved
Veliparib
Not yet FDA approved
Find a Location
Who is running the clinical trial?
AbbottIndustry Sponsor
750 Previous Clinical Trials
478,236 Total Patients Enrolled
1 Trials studying Breast Cancer
40 Patients Enrolled for Breast Cancer
Steven J Isakoff, MD, PhDLead Sponsor
Dana-Farber Cancer InstituteOTHER
1,078 Previous Clinical Trials
340,808 Total Patients Enrolled
141 Trials studying Breast Cancer
22,553 Patients Enrolled for Breast Cancer
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger