Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic BRCA Mutant Metastatic Breast Cancer: Genotyping Based Clinical Trial
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|ClinicalTrials.gov Identifier: NCT03990896|
Recruitment Status : Recruiting
First Posted : June 19, 2019
Last Update Posted : November 2, 2022
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Talazoparib||Phase 2|
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
The U.S. Food and Drug Administration (FDA) has not approved talazoparib for the participants' specific disease but it has been approved for metastatic breast cancer with a germline (inherited) BRCA mutation.
Talazoparib is a study drug that inhibits (stops) the normal activity of certain proteins called "poly (ADP-ribose) polymerases" also called "PARPs". PARPs are proteins (made from genes which are part of your DNA) that are found in all normal and cancer cells that are involved in the repair of DNA. PARPs are needed to repair mistakes that can happen in DNA when cells divide. If the mistakes are not repaired, the defective cell will usually die and be replaced. Cells with mistakes in their DNA that do not die can become cancer cells. Cancer cells may be killed by a study drug, like talazoparib, that stops the normal activity of PARPs. In clinical trials, the use of talazoparib and other PARP inhibitors have shown that these drugs can reduce tumor size and slow tumor growth in some cancer patients with BRCA1 or BRCA2 mutations.
In this research study, the investigators are examining how effective talazoparib is in patients with metastatic breast cancer with a BRCA mutation in their tumor.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic BRCA Mutant Metastatic Breast Cancer: Genotyping Based Clinical Trial|
|Actual Study Start Date :||November 18, 2021|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||July 31, 2024|
-Talazoparib will be provided as capsules for oral administration daily
Talazoparib is a study drug that inhibits (stops) the normal activity of certain proteins called "poly (ADP-ribose) polymerases" also called "PARPs". PARPs are proteins (made from genes which are part of DNA) that are found in all normal and cancer cells that are involved in the repair of DNA. PARPs are needed to repair mistakes that can happen in DNA when cells divide. If the mistakes are not repaired, the defective cell will usually die and be replaced. Cells with mistakes in their DNA that do not die can become cancer cells.
Other Name: Talzenna
- Median Progression Free Survival [ Time Frame: From the start of treatment until death or disease progression, up to approximately 2 years ]Progression-Free Survival (PFS) is defined as the time from the first dose of study treatment to the date of disease progression as assessed by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death due to any cause, whichever occurs first. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
- Objective Response Rate [ Time Frame: From the start of treatment until treatment discontinuation, up to approximately 2 years ]
The number of participants that achieve either a complete (CR) or partial response (PR) according to RECIST 1.1.
- CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
- PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- Number of Participants with Treatment-related Serious Adverse Events [ Time Frame: From the start of treatment until treatment discontinuation, up to approximately 2 years ]Adverse events will be assessed using Common Terminology Criteria for Adverse Events (CTCAE 5). The number of participants with grade 3 or greater adverse events that were deemed to be possibly, probably, or definitely related to study treatment will be reported.
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): NCT03990896
|Contact: Neelima Vidula, MDfirstname.lastname@example.org|
|United States, California|
|UCSF Medical Center-Mission Bay/Benioff Children's Hospital||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Hope Rugo, MD 415-353-7070 email@example.com|
|Principal Investigator: Hope Rugo, MD|
|United States, Georgia|
|Emory University Winship Cancer Institute||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Manali Bhave, MD 404-778-3969 firstname.lastname@example.org|
|Principal Investigator: Manali Bhave, MD|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Ami Shah, MD 630-886-6967 email@example.com|
|Principal Investigator: Ami Shah, MD|
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Neelima Vidula, MD 617-724-4000 firstname.lastname@example.org|
|Principal Investigator: Neelima Vidula, MD|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Senthil Damodaran, MD, PhD 713-792-2817 email@example.com|
|Principal Investigator: Senthil Damodaran, MD, PhD|
|Principal Investigator:||Neelima Vidula, MD||Massachusetts General Hospital|