Health Condition 1: C50- Malignant neoplasm of breast
Conditions
Interventions
Intervention1: Neoadjuvant radiotherapy-Hypofractionated arm: Neoadjuvant radiotherapy given at the dose of 40Gy/15F delivered over 3 weeks
Intervention2: Neoadjuvant radiotherapy arm: Neoadjuvant rad
Sponsors
Tata Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age = 18 years 2. Patients must have a pathological proof of an invasive epithelial breast malignancy at the treating institute. A core biopsy with adequate specimen quality is necessary for this. FNAC alone is not sufficient. Biopsies taken outside must have been reviewed for pathological confirmation and specimen adequacy at the treating institute.Patients with ductal and lobular cancers are eligible for the study. 3. Receptor status (Oestrogen receptor, Progesterone receptor and HER2 neu receptor) status should be documented. Patients can be enrolled with an equivocal HER2neu receptor report but in all such cases a confirmatory in-situ hybridisation should be done to confirm the status prior to initiation of taxane based chemotherapy. 4. ECOG performance status 0 - 2. 5. Clinical stage I - III disease as documented with adequate pretreatment staging. Adequate staging include either of the two following options: a. Whole body 18-FDG PET CT (preferred) b. Contrast enhanced CT scan of the thorax and abdomen and a bone scan. Note that chest X ray or USG abdomen are not acceptable substitutes. 6. Patients should have been planned for neoadjuvant chemotherapy as per institutional protocol. 7. Patients with tumour that is likely to be amenable for curative intent resection of the breast primary, following neoadjuvant therapy. 8. If the patient had nodal disease in the supraclavicular fossa (proven pathologically) or internal mammary nodes (proven radiologically or pathologically), then residual gross nodes should not be present in these regions post NACT.
Exclusion criteria
Exclusion criteria: 1. Patients planned for therapeutic mammoplasty. 2. Patients planned for chest wall perforator flaps. This criteria will be re-evaluated after the data from the perforator substudy is available and has been reviewed by the DSMC. 3. Patients with non-epithelial malignant conditions of breast viz. Sarcomas, lymphomas and phyllodes breast tumours. 4. Patients with skin cancer affecting the breast. 5. Prior radiotherapy to the ipsilateral breast or chest wall or mediastinum. 6. Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety 7. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol. Patients enrolled for trials of investigational drugs should not be enrolled for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any Breast cancer recurrence, local/regional/distant, development of ipsilateral or contralateral invasive breast cancer, ductal carcinoma in situ or any invasive second malignancy or deathTimepoint: At 7 Years | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional cancer outcomes: Overall survival, Locoregional recurrence free survival, Distant metastasis free survival Patient reported outcomes Clinician reported toxicity Timepoint: At 3 years ;Patient reported breast / chest wall indurationTimepoint: At 3 years | — |
Countries
India
Contacts
Public ContactDr Sanjoy Chatterjee
Tata Medical Centre, Kolkata
Outcome results
None listed