ABT-888 and Temozolomide for Metastatic Breast Cancer and BRCA1/2 Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01009788|
Recruitment Status : Active, not recruiting
First Posted : November 9, 2009
Last Update Posted : August 26, 2019
The purpose of this research study is to find out if the combination of ABT-888 and temozolomide is safe and effective in treating patients with metastatic breast cancer. ABT-888 works by obstructing a DNA enzyme called poly (ADP-ribose) polymerase (PARP) which helps repair cancer cells damaged by chemotherapy. By blocking the PARP enzyme, the cancer cells are unable to repair themselves and as a result die. The other drug in this study is temozolomide. Temozolomide is designed to damage DNA in order to prevent cancer cells from reproducing. Because PARP inhibitors, such as ABT-888, prevent cancer cells from repairing their own DNA, they enhance the potential of chemotherapy therapy like temozolomide to induce cell death. The combination of ABT-888 and temozolomide has been used in a clinical trial for treatment of other cancers and information for this research study suggests that the combination may help to inhibit growth in breast cancer.
ONLY THE EXPANSION COHORT BELOW IS RECRUITING:
BRCA CARRIER EXPANSION COHORT: The purpose of the expansion cohort is to further evaluate the activity and safety of this combination in BRCA mutation carriers with metastatic breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Metastatic Breast Cancer BRCA1 Gene Mutation brca2 Gene Mutation||Drug: ABT-888 Drug: temozolomide||Phase 2|
- Each treatment cycle lasts 28 days. Participants will be given a supply of ABT-88 in the form of capsules which they will take twice daily on days 1-7 of each cycle. Temozolomide is also in capsule form and will be taken once daily on days 1-5 of each cycle.
- Participants will come into the clinic on day 1 of each cycle and will have the following tests and procedures performed: physical examination, vital signs and blood tests.
- On day 15 of cycles 1 and 2 and day 22 of each cycle, participants will have blood work done.
- An assessment fo the tumor by CT scan of the participants chest, abdomen and pelvis will be done every 2 cycles.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of ABT-888 and Temozolomide for Metastatic Breast Cancer and an Expansion Cohort in BRCA1/2 Mutation Carriers|
|Study Start Date :||November 2009|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
Combination therapy with temozolomide and veliparib
Capsules taken orally twice a day on days 1-7 of each 28 day cycle
Other Name: veliparib
capsules taken orally once a day on days 1 through 5 of a 28 day cycle
Other Name: TMZ
- To determine the objective response rate (ORR) of ABT-888 and temozolomide (TMZ) in metastatic breast cancer. [ Time Frame: 2 years ]To determine the percentage of all enrolled patients who have a partial or complete response
- To determine Safety and Efficacy in an Expansion Cohort of BRCA1/2 Mutation Carriers. [ Time Frame: 2 years ]An expansion cohort of 20 additional patients with BRCA1/2 Deleterious Mutations will be evaluated to further assess safety and efficacy of the combination of ABT888 and Temozolomide in metastatic breast cancer.
- To further characterize the safety and tolerability of ABT-888 and TMZ in patients with metastatic breast cancer. [ Time Frame: 2 years ]
- To evaluate progression free survival. [ Time Frame: 5 years ]To determine the median time to progression of all patients
- To evaluate the clinical benefit rate. [ Time Frame: 2 years ]to determine the percentage of patients who achieve a partial or complete response or stable disease
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01009788
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02115|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Steven Isakoff, MD, PhD||Massachusetts General Hospital|