ABT-888 for Metastatic Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Metastatic Breast Cancer+3 MoreABT-888 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Metastatic Breast Cancer
  • Breast Cancer
  • BRCA1 Gene Mutation
  • BRCA2 Gene Mutation

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: 5 years

2 years
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.
To evaluate the clinical benefit rate.
To further characterize the safety and tolerability of ABT-888 and TMZ in patients with metastatic breast cancer.
5 years
To evaluate progression free survival.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

ABT-888 and Temozolomide
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%Lymphopenia
3%Fever
3%Dizziness
3%Shortness of breath
3%Constipation
1%Elevated creatinine
1%Rash
1%Weight loss
1%Ascites
1%Dehydration
1%Petechiae/Purpura
1%Urinary Hemorrhage
1%Vaginal hemorrhage
1%Hypoalbuminemia
1%Edema: limb
1%Cough
1%Febrile neutropenia
1%Alopecia
1%Peeling of feet
1%Dysphagia
1%Dysgeusia
1%Headache
This histogram enumerates side effects from a completed 2013 Phase 2 trial (NCT01051596) in the ABT-888 and Temozolomide ARM group. Side effects include: Thrombocytopenia with 53%, Nausea with 48%, Anemia with 47%, Fatigue with 25%, Leucopenia with 20%.

Trial Design

1 Treatment Group

TMZ/ABT888
1 of 1

Experimental Treatment

64 Total Participants · 1 Treatment Group

Primary Treatment: ABT-888 · No Placebo Group · Phase 2

TMZ/ABT888Experimental Group · 2 Interventions: temozolomide, ABT-888 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
FDA approved
Veliparib
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years

Who is running the clinical trial?

Dana-Farber Cancer InstituteOTHER
1,016 Previous Clinical Trials
393,734 Total Patients Enrolled
15 Trials studying Metastatic Breast Cancer
1,065 Patients Enrolled for Metastatic Breast Cancer
Beth Israel Deaconess Medical CenterOTHER
777 Previous Clinical Trials
845,690 Total Patients Enrolled
3 Trials studying Metastatic Breast Cancer
114 Patients Enrolled for Metastatic Breast Cancer
AbbottIndustry Sponsor
731 Previous Clinical Trials
477,273 Total Patients Enrolled
Steven J Isakoff, MD, PhDLead Sponsor
Steven Isakoff, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
3 Previous Clinical Trials
138 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Breast cancer patients with HER2 positive disease must have progressed on prior standard HER2 therapy or have a contraindication to anti-HER2 therapy.
You have received prior chemotherapy for metastatic disease
You have metastatic or locally advanced breast cancer that is unresectable or no longer effective.
You have measurable disease by RECIST criteria.
You are eligible for the test if you are at least 18 years of age.
You must be able to complete the study and must have a life expectancy of at least 12 weeks.