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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
Must not have
History of uncontrolled seizure disorder
Leptomeningeal disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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My breast cancer has worsened despite HER2 therapy or I can't have HER2 treatment.
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My current cancer treatment is not working.
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My breast cancer is advanced, cannot be surgically removed, and standard treatments are not effective.
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I am 18 years old or older.
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I have had at least one chemotherapy treatment for my cancer after it spread.
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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of seizures that are not controlled by medication.
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My cancer has spread to the lining of my brain and spinal cord.
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I am not receiving any other cancer treatments while on this study.
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I am not receiving radiation therapy while participating in this study.
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I do not have any serious illnesses or conditions that my doctor thinks could make it unsafe for me to join the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
To evaluate progression free survival.
To evaluate the clinical benefit rate.

Side effects data

From 2013 Phase 2 trial • 75 Patients • NCT01051596
53%
Thrombocytopenia
48%
Nausea
47%
Anemia
25%
Fatigue
20%
Leucopenia
19%
Vomiting
17%
Neutropenia
12%
Anorexia
7%
Diarrhea
4%
Pain NOS
4%
Neuropathy: sensory
3%
Dizziness
3%
Shortness of breath
3%
Lymphopenia
3%
Fever
3%
Constipation
1%
Febrile neutropenia
1%
Alopecia
1%
Peeling of feet
1%
Edema: limb
1%
Cough
1%
Elevated creatinine
1%
Vaginal hemorrhage
1%
Rash
1%
Urinary Hemorrhage
1%
Headache
1%
Hypoalbuminemia
1%
Weight loss
1%
Petechiae/Purpura
1%
Ascites
1%
Dysphagia
1%
Dysgeusia
1%
Dehydration
100%
80%
60%
40%
20%
0%
Study treatment Arm
ABT-888 and Temozolomide

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Veliparib
Not yet FDA approved
Temozolomide
FDA approved

Find a Location

Who is running the clinical trial?

AbbottIndustry Sponsor
753 Previous Clinical Trials
479,171 Total Patients Enrolled
Steven J Isakoff, MD, PhDLead Sponsor
Dana-Farber Cancer InstituteOTHER
1,108 Previous Clinical Trials
357,173 Total Patients Enrolled
~4 spots leftby Nov 2025
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