Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03499353|
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : March 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Early Breast Cancer||Drug: TALAZOPARIB||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||THIS IS AN OPEN LABEL SINGLE ARM STUDY|
|Masking:||None (Open Label)|
|Official Title:||A PHASE 2, NON-RANDOMIZED, OPEN LABEL, SINGLE ARM, MULTI-CENTER STUDY OF TALAZOPARIB FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE BREAST CANCER|
|Actual Study Start Date :||August 27, 2018|
|Estimated Primary Completion Date :||December 2, 2020|
|Estimated Study Completion Date :||March 1, 2023|
SINGLE ARM, NON-RANDOMIZED
- Pathological Complete Response (pCR) by Independent Central Reviewer(ICR) [ Time Frame: Following the completion of 24 weeks of Talazoparib Treatment ]Pathological Complete Response(pCR) by Independent Central Reviewer (ICR) defined by: defined as ypT0/Tis ypN0 (the absence of residual invasive cancer in the breast and the axillary lymph nodes on evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy).
- pCR by Investigator [ Time Frame: Following the completion of 24 weeks of Talazoparib Treatment ]pCR rate by investigator is defined as the number and percentage of patients achieving pCR by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all patients in the evaluable population.
- Residual Cancer Burden(RCB) by Independent reviewer [ Time Frame: Following the completion of 24 weeks of Talazoparib Treatment ]Residual cancer burden by ICR will be reported as a categorical variable with four classes (categories) RCB 0 (pCR), I (minimal RCB), II (moderate RCB), and III (extensive RCB).
- pCR by independent Reviewer in Breast [ Time Frame: Following the completion of 24 weeks of Talazoparib Treatment ]pCR rate in breast by ICR is defined as the number and percentage of patients achieving pCR in breast by independent central review after talazoparib treatment for 24 weeks, followed by surgery, among all patients in the evaluable population
- Event Free Survival [ Time Frame: Time of Surgery up to 36 months ]Time of surgery to first documentation of local or distant recurrence, or death or initiation of antineoplastic therapy before documentation of first relapse
- Overall Survival [ Time Frame: First Dose of Talazoparib up to 42 months ]Time from the first dose of Talazoparib to death due to any cause
- Incidence of Adverse Events [ Time Frame: Upon signing Informed Consent up to 42 months ]Type, incidence, severity (as graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v4.03), seriousness and relationship of study medications to adverse events (AE) and any laboratory abnormalities
- Patient Reported Outcome: Deterioration of Global Health Status [ Time Frame: First dose of Talazoparib up to 9 months ]Time to definitive deterioration of Global Health Status per EORTC QLQ-C30
- Patient Reported Outcome: Nausea and vomiting symptoms [ Time Frame: First dose of Talazoparib up to 9 months ]Time to definitive deterioration in nausea and vomiting symptoms per EORTC QLQ C30
- Patient Reported Outcome: global health status/QoL, functioning, and symptoms [ Time Frame: First dose of Talazoparib up to 9 months ]Change from baseline in global health status/QoL, functioning, and symptoms per EORTC QLQ C30 and EORTC QLQ BR 23
- Patient Reported Outcome- Antiemetic Log [ Time Frame: First dose of Talazoparib up to 9 months ]Proportion of patients with deterioration, improvement and no change in nausea and vomiting symptoms.
- Patient Reported Outcome: Missed Menstrual Period [ Time Frame: First dose of Talazoparib up to 9 months ]Change from baseline in proportion of patients with missed expected menstrual period per PRO CTCAE
- Pharmacokenetic assessment of Talazoparib [ Time Frame: week 4, week 8, week 12 ]Plasma concentration of talazoparib
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): NCT03499353
|Contact: Pfizer CT.gov Call Center||1-800-718-1021||ClinicalTrials.gov_Inquiries@pfizer.com|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|