| 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
|
|
|
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. |