Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Tata Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: To be included in the trial the patient must: 1.Have given written informed consent to participate for the study according to national/local regulations 2. Be aged over 18 years? old 3. ECOG performance status 0, 1 or 2 4. Patient with histological diagnosis of AJCC Stage 1, 2, 3 or 4 invasive breast cancer (the presence of high grade DCIS is acceptable), including new loco-regional relapse or new metastatic lesion. 5. Patients scheduled for a biopsy/surgical procedure of the new lesion or fresh tissue available for research
Exclusion criteria
Exclusion criteria: Presence of any psychological, family, sociological or geographic condition potentially hampering compliance with the study protocol and follow-up schedule.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main outcome: Proportion of patients that receive personalised treatment based on genomic results. Timepoint: 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate the impact of genome-driven personalised medicine on breast cancer outcomes at 3 years in a non-selective, real-world setting. 2.To assess the effect of a genomic profiling programme on the identification of patients for clinical trials inclusion in a breast cancer population of all stages of disease. 3.To describe the influence of WGS on categories of clinical management: surgery; referral to clinical genetics; genomic-directed therapy change; genomic-directed toxicity management change; genomic-guided recommendation for future therapy. 4.To characterise molecular profiles or mutation signatures of breast cancer patients (both tumour and germline) with subsequent stratification of patients, and correlation of these profiles with clinical outcomes. 4.To ascertain the TME on tissue blocks and study its associations to the various molecular subtypes Timepoint: 5 years | — |
Countries
India
Contacts
Public ContactDr Sanjoy Chatterjee
Tata Medical Centre, Kolkata
Outcome results
None listed