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Gene testing in triple negative breast cancer at two points: before and after chemotherapy

Recruiting
Conditions
Malignant neoplasm of breast,
Registration Number
CTRI/2022/05/042779
Lead Sponsor
ICMR
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Female
Target Recruitment
100
Inclusion Criteria

Patients diagnosed with triple negative breast cancer Non metastatic disease Planned for neoadjuvant chemotherapy Willing to participate in study.

Exclusion Criteria

Patients with prior history of cancer Patients planned for upfront surgery.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Identification of targetable mutations in residual disease in triple negative breast cancer that were not initially present in the tumor cells and in germlineSix months
Secondary Outcome Measures
NameTimeMethod
Identifying the associations between differential mutations with disease-free survival of patients with triple negative breast cancerIdentification of genetic mutations associated with incomplete response to chemotherapy

Trial Locations

Locations (1)

AIIMS New Delhi

🇮🇳

South, DELHI, India

AIIMS New Delhi
🇮🇳South, DELHI, India
Atul Batra
Principal investigator
01129575043
batraatul85@gmail.com

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