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CTRI Number  CTRI/2024/10/076008 [Registered on: 29/10/2024] Trial Registered Prospectively
Last Modified On: 28/10/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective study 
Study Design  Other 
Public Title of Study   Retrospective data collection and analysis of patients who had received Talzopari drug 
Scientific Title of Study   Retrospective observational study of safety and efficacy of Talazoparib in BRCA1/2 or PALB2 mutation breast cancer. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sudeep Gupta 
Designation  Director TMC and Professor Medical Oncology 
Affiliation  Tata Memorial Center 
Address  Department of Medical Oncology Room No: 1109, 11 floor, Homi Bhabha Building Tata Memorial Center Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177201  
Fax  02224177201  
Email  sudeepgupta04@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sudeep Gupta 
Designation  Director TMC and Professor Medical Oncology 
Affiliation  Tata Memorial Center 
Address  Department of Medical Oncology Room No: 1109, 11 floor, Homi Bhabha Building Tata Memorial Center Parel


MAHARASHTRA
400012
India 
Phone  02224177201  
Fax  02224177201  
Email  sudeepgupta04@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Yogesh Kembhavi 
Designation  Research Manager 
Affiliation  Tata Memorial Center 
Address  Department of Medical Oncology Room no: 1109, 11 floor, Homi Bhabha Building Tata Memorial Center Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  09967594597  
Fax    
Email  yogeshkembhavi1@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Centre E Borges Marg Parel 400012 Maharastra India 
 
Primary Sponsor  
Name  Not applicable 
Address  Not applicable 
Type of Sponsor  Other [Not applicable, no funding required.] 
 
Details of Secondary Sponsor  
Name  Address 
Not applicable  Not applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sudeep Gupta  Tata Memorial Centre  Department of Medical Oncology 1109, 11 floor, Homi Bhabha Building. Tata Memorial Hospital
Mumbai
MAHARASHTRA 
02224177201
02224177201
sudeepgupta04@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  NA 
Comparator Agent  Nil  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. All patients who were included in Talazoparib patient access program. To be enrolled in the program, patients were required to have fulfilling the following criteria.
- Patients with age 18 years or older with any gender and diagnosed with a deleterious, suspected deleterious, or pathogenic germline BRCA1/2 or PALB2 mutation breast will be included in the analysis.
- At least 1 EMR record of followup, post initiation of study treatment.
 
 
ExclusionCriteria 
Details  1. No available EMR records 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary objective of the study is to find the PFS of patients treated with talazoparib as a
monotherapy.  
1 year 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary objectives of the study are to evaluate the following:
1. Objective response rate (ORR)
2. Overall survival (OS)
3. Safety of talazoparib
The exploratory objectives are to evaluate the duration of response (DOR) for objective
responders. 
1 year 
 
Target Sample Size   Total Sample Size="6"
Sample Size from India="6" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
The study is a single arm, retrospective cohort study of patients with a deleterious, suspected
deleterious, or pathogenic germline BRCA1/2 or PALB2 mutation breast cancer.
Treatment pattern with Talazoparib, discontinuation due to disease progression, unacceptable toxicity,
consent withdrawal or physician discretion will be studied.
Patients who were discontinued from study medication for any reason other than radiographic disease
progression as determined by the IRF or initiation of a new antineoplastic therapy will be followed to
radiographic progression by imaging assessments (eg, computed tomography [CT] scans).
Patients with altleast one available medical record on EMR will be included in the analysis.
Progression free survival, overall survival and toxicity will be studied.
Response will be assessed post evaluation of age, menopausal status, baseline tumor characteristics,
ECOG, metastatic sites, comorbidities, previous anticancer treatment like surgery, radiation,
chemotherapy lines received, ET lines, other ongoing treatments for comorbidities, visceral, non
visceral disease.
Data will be collected through EMR from all available records and reports such as blood
investigations, radiological reports, physician notes and histopathological reports to assess the
primary objective of the trial. Response will be calculated from the day of starting of Talazoparib to
date of last dose. Toxicity will be graded as per CTCAE V 4.03. Adverse events and tolerability will
be assessed along with time to recover from the toxicity. Dose reductions and interruptions will be
studied.
 
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