Gene testing in triple negative breast cancer at two points: before and after chemotherapy
- 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
Patients diagnosed with triple negative breast cancer Non metastatic disease Planned for neoadjuvant chemotherapy Willing to participate in study.
Patients with prior history of cancer Patients planned for upfront surgery.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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
Trial Locations
- Locations (1)
AIIMS New Delhi
🇮🇳South, DELHI, India
AIIMS New Delhi🇮🇳South, DELHI, IndiaAtul BatraPrincipal investigator01129575043batraatul85@gmail.com