COmparing GENomic patterns in Triple negative breast cancer
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2022/02/040498
- Lead Sponsor
- Department of Science and Technology Government of India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria:
1.Signed and written informed consent approved by the Ethical Review Board.
2.Age 18+ years
3.ER & PR-negative tumor defined by at least one of the following:
a.ER < 1% and PR <1% positive cells by IHC
4.HER2-normal tumor defined by at least one of the following:
a.HER2 0 or 1+ by immunohistochemistry
b.HER2 2+ by IHC and HER2 to centromere 17 ratios < 2.0 and/or less than 6 copies by in situ hybridization (ISH).
5.Consent for germline mutation screening for BRCA1, BRCA2, and other inherited breast cancer-associated genes.
Exclusion Criteria:
1.On previous therapy such as chemotherapy, radiation, surgery, inhibitor therapy, etc.
2.A patient who is either pregnant or actively breastfeeding.
3.Has comorbidities that might hinder the study or its processes. Including severe cardiovascular disorders, haematological disorders, chronic neurological or renal disorders, inadequate organ function, inflammatory or infectious diseases, etc.
4.Allergy to any of the procedures involved in the study.
5.Unable to tolerate the position or procedure needed to be undergone during the study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Assessment of genetic expression in paired liquid and tissue biopsies from treatment-naive TNBC patients. In addition, we will assess the quantity and quality of circulating tumor DNA (ctDNA) in the liquid biopsy samples. <br/ ><br> <br/ ><br>2.Establish similarities and differences in mutation/phenotypes of ctDNA and tumor samples obtained from liquid biopsies and TNBC tissue biopsies, respectively. <br/ ><br>Timepoint: Outcome will be assessed after completion of the study <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Assessment of post therapy changes in the genomic landscape on blood and tissue biopsies with respect to the pre treatment baseline values. <br/ ><br> <br/ ><br>2.Establish the consequential impact of the genomic landscape with respect to the susceptibility and responsiveness towards the given therapy. <br/ ><br>Timepoint: 01 JANUARY 2022 TO 01 JANUARY 2024