To evaluate changes in its DNA and RNA makeup in the tumor of any given patient over the course of her metastatic cancer

Not Applicable

Completed

• Conditions: Health Condition 1: null- Breast Cancer

• Registration Number: CTRI/2016/11/007430
• Lead Sponsor: SCIENCE ENGINEERING RESEARCH BOARD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-12-17
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 9

Inclusion Criteria

Patients just diagnosed with recurrent/metastatic breast cancer after a previous diagnosis and treatment of non-metastatic breast cancer OR de nevo metastatic breast cancer

Patients whose primary tumors are stored in the Tumor Tissue Repository of Tata Memorial Hospital in liquid nitrogen

Patients willing to provide written informed consent to participate in the study including biopsies from recurrent/metastatic sites and longitudinal follow-up in their metastatic course

Patients in whom biopsy from recurrent/metastatic sites can be performed with reasonable safety

Patients whose tumors are triple negative by IHC (ER-/PR-/HER2-)

Patients willing to receive the usual standard treatment for metastatic breast cancer

Exclusion Criteria

No exclusion criteria

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare sequential biopsies obtained at successive transition points to determine the impact of progression of the disease and treatment on tumor heterogeneity <br/ ><br> <br/ ><br>To determine whether breast cancer progression is parallel or sequential <br/ ><br> <br/ ><br>To determine the role of/ degree of clonal selection during the various transitions through defined clinical stages from primary tumor to end stage disease <br/ ><br> <br/ ><br>Identify novel targets and assess their role as drivers in the progression of the disease <br/ ><br> <br/ ><br>Timepoint: Patients with Triple negative breast cancer detected with newly developed metastatic breast cancer after a previous diagnosis and treatment of non-metastatic breast cancer (whose primary tumors are archived in the TMH Tumor Tissue Repository) OR de nevo metastatic breast cancer

Secondary Outcome Measures

Name	Time	Method
ilTimepoint: Nil