Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
None listed
Sponsors
Department of Science and Technology Government of India
Eligibility
Inclusion criteria
Inclusion criteria: 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 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 5. Consent for germline mutation screening for BRCA1, BRCA2, and other inherited breast cancer-associated genes.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 2. Establish similarities and differences in mutation/phenotypes of ctDNA and tumor samples obtained from liquid biopsies and TNBC tissue biopsies, respectively. Timepoint: Outcome will be assessed after completion of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Assessment of post therapy changes in the genomic landscape on blood and tissue biopsies with respect to the pre treatment baseline values. 2.Establish the consequential impact of the genomic landscape with respect to the susceptibility and responsiveness towards the given therapy. Timepoint: 01 JANUARY 2022 TO 01 JANUARY 2024 | — |
Countries
India
Contacts
Public ContactAvinash Eranki
Indian Institute of Technology, Hyderabad
Outcome results
None listed