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Trial record 1 of 1 for:    NCT03499353
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Talazoparib For Neoadjuvant Treatment Of Germline Brca1/2 Mutation Patients With Early Triple-negative Breast Cancer

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ClinicalTrials.gov Identifier: NCT03499353
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE April 9, 2018
First Posted Date  ICMJE April 17, 2018
Last Update Posted Date June 17, 2019
Actual Study Start Date  ICMJE August 27, 2018
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2019)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: April 9, 2018)
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, ypN0 (the absence of residual invasive and in situ cancer on evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy).
Change History Complete list of historical versions of study NCT03499353 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Talazoparib For Neoadjuvant Treatment Of Germline Brca1/2 Mutation Patients With Early Triple-negative Breast Cancer
Official Title  ICMJE 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 TRIPLE-NEGATIVE BREAST CANCER
Brief Summary 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 TRIPLE NEGATIVE BREAST CANCER
Detailed Description TALAZOPARIB (PARP INHIBITOR) FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY TRIPLE NEGATIVE BREAST CANCER. THIS IS A MONOTHERAPY TREATMENT FOR 24 WKS FOLLOWED BY SURGERY TO EVALUATE PATHOLOGICAL COMPLETE RESPONSE.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
THIS IS AN OPEN LABEL SINGLE ARM STUDY
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Early Breast Cancer
Intervention  ICMJE Drug: TALAZOPARIB
Talazoparib 1mg/day
Study Arms  ICMJE Experimental: TALAZOPARIB
SINGLE ARM, NON-RANDOMIZED
Intervention: Drug: TALAZOPARIB
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 9, 2018)
122
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2023
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Germline BRCA 1/2 Mutation Positive
  • Women and men at least 18 years of age or older.
  • Histologically confirmed invasive triple negative Breast Cancer
  • Tumor greater than or equal toT1
  • No evidence of distant metastasis
  • Adequate bone marrow, hepatic, and renal function
  • ECOG performance status 0 or 1

Exclusion Criteria:

  • Any other previous antitumor therapies for the current cancer event. Treatment for ductal carcinoma in situ (DCIS) is allowed; ie, surgery, hormonal therapy and radiation.
  • Evidence of distant metastasis apparent prior to randomization
  • Patients with inflammatory breast carcinoma
  • Malignancy within the last 3 years, except:: Adequately treated non melanoma skin cancer; Curatively treated in situ cancer of the cervix; Stage 1, Grade 1 endometrial carcinoma; or Adequately treated contralateral breast carcinoma which has been disease free for a year; Other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for 5 years.
  • Previous or concomitant systemic anti cancer therapies used for the treatment of cancer in the last 3 years.
  • Prior treatment with a PARP inhibitor in any disease setting
  • Concomitant use of Strong P gp inhibitors or inducers or BCRP inhibitors
  • Patients who are unwilling or unable to use 2 highly effective methods of contraception as outlined in this protocol
  • Major surgery within 14 days prior to study entry
  • Known history of cardiac disease, for example : Myocardial infarction or symptomatic cardiac ischemia within 24 weeks before screening; Congestive heart failure New York Heart Association Class III or IV; History of clinically significant ventricular arrhythmias within one year prior to randomization; History of Mobitz II second degree or third degree heart block, uncontrolled hypertension.
  • Active clinically significant infection
  • Clinically significant bleeding diathesis or coagulopathy
  • Non healing wound, ulcer or bone fracture
  • Known hypersensitivity to any of the components of talazoparib
  • Patients with myelodysplastic syndrome/acute myeloid leukemia
  • Patients with uncontrolled seizures.
  • Any evidence of other disease or any concomitant medical or psychiatric problems which in the opinion of the Investigator would prevent completion of treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03499353
Other Study ID Numbers  ICMJE C3441020
TALAZOPARIB NEOADJ BC ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP