| CTRI Number |
CTRI/2022/05/042779 [Registered on: 24/05/2022] Trial Registered Prospectively |
| Last Modified On: |
25/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Gene testing in triple negative breast cancer at two points: before and after chemotherapy |
|
Scientific Title of Study
|
Paired targeted genomic profiling of triple negative breast cancer to understand the mechanisms of chemoresistance and develop novel treatment targets |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Atul Batr |
| Designation |
Associate professor |
| Affiliation |
AIIMS |
| Address |
Room 160D
First Floor
IRCH
AIIMS
South
DELHI
110029
India |
| Phone |
01129575043 |
| Fax |
|
| Email |
batraatul85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Atul Batr |
| Designation |
Associate professor |
| Affiliation |
AIIMS |
| Address |
Room 160D
First Floor
IRCH
AIIMS
DELHI
110029
India |
| Phone |
01129575043 |
| Fax |
|
| Email |
batraatul85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Atul Batr |
| Designation |
Associate professor |
| Affiliation |
AIIMS |
| Address |
Room 160D
First Floor
IRCH
AIIMS
DELHI
110029
India |
| Phone |
01129575043 |
| Fax |
|
| Email |
batraatul85@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
ICMR
. Ramalingaswami Bhawan, P.O. Box No. 4911. Ansari Nagar, New Delhi - 110029, India. |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Atul Batra |
AIIMS New Delhi |
Room 160 D, First Floor
IRCH, AIIMS
South
DELHI |
01129575043
batraatul85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics CommitteeAIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Patients diagnosed with triple negative breast cancer
Non metastatic disease
Planned for neoadjuvant chemotherapy
Willing to participate in study |
|
| ExclusionCriteria |
| Details |
Patients with prior history of cancer
Patients planned for upfront surgery |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identification of targetable mutations in residual disease in triple negative breast cancer that were not initially present in the tumor cells and in germline |
Six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Identifying the associations between differential mutations with disease-free survival of patients with triple negative breast cancer
Identification of genetic mutations associated with incomplete response to chemotherapy
Identification of new mutations that develop in recurrent disease
|
Six months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/06/2022 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is expected that 232,832 patients will be diagnosed with breast cancer in India in 2025. Triple-negative breast cancer (TNBC) is a subtype that does not express estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2) andtherefore, such patients do not benefit from hormonal or HER2 directed
therapy. The current standard of management of patients with TNBC more than 2 cm primary tumor size is neoadjuvant chemotherapy, followed by surgery and subsequently radiotherapy, as indicated. Despite this, around 50% of patients with TNBC will eventually developchemoresistance, recur systemically and succumb to cancer. The mechanisms of chemoresistance in the residual tumor tissue are not known. To addressthis knowledge gap, we aim to compare the targeted genomic (germline and somatic) profiles of baseline tumor samples with that of post-neoadjuvant chemotherapy surgical specimenfrom a prospective cohort of patients with TNBC. |