Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Preoperative radiotherapy in breast cancer after neoadjuvant chemotherapy: Radiation: preoperative radiotherapy given 2 weeks post NACT or count recovery at a dose of 26Gy in 5 fraction
Sponsors
All India Institute of Medical Sciences, Jodhpur
Eligibility
Inclusion criteria
Inclusion criteria: 1)Eligibility for NACT: Patients with inoperable breast cancer: a)Bulky or matted cN2 axillary nodes b)cN3 nodal disease c)cT4 tumors(Inflammatory breast cancer if disease can be contained in radiotherapy portal) In select patients with operable breast cancer: a)HER2-positive disease and TNBC, if =cT2 or =cN1 b)Large primary tumor relative to breast size in a patient who desires breast conservation. c)cN+ disease likely to become cN0 with preoperative systemic therapy. d)cT1c, cN0, HER2-positive disease and TNBC. 2)Pathological evidence of breast cancer 3)Informed consent for NACT signed by the patient 4)Absence of Distant mets 5)Age =18 years at the time of randomisation 6)Performance status = 2
Exclusion criteria
Exclusion criteria: 1)Pregnancy or lactation 2)Prior radiotherapy of the affected or contralateral breast 3)Connective tissue disease, including rheumatoid arthritis and thromboangiitis obliterans 4)Cardiac comorbidities: symptomatic coronary heart disease, prior heart attack, heart failure NYHA II or AHA C, pacemaker, and/or implanted defibrillator 5)Other medical conditions that prohibit the neoadjuvant chemotherapy (i.e. psychiatric diseases, non-compliance, etc.) 6)Patients with pure ductal carcinomas in situ. 7)Patients with non-epithelial malignant conditions of the breast viz. Sarcomas, lymphomas, phyllodes tumors 8)Synchronous primary
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete responseTimepoint: Post surgical resection(Post BCS or MRM) in both arms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of Acute radiation ToxicityTimepoint: Pre RT and Post RT;Assessment of arm lymphedema ratesTimepoint: 0,6 months and then yearly for 5 years;Assessment of Brachial plexopathyTimepoint: Baseline and then yearly for 5 years;Assessment of cosmetic results by the physiciansTimepoint: 5 years;Assessment of Radiation Doses to critical structures and Organs at risk.Timepoint: Post Radiotherapy;Decrease in Ki67 post Neoadjuvant therapyTimepoint: Post Surgery;Disease free survival (DFS)Timepoint: 5 years;Disease metastases free survival (DMFS)Timepoint: 5 years;Disease specific survival (DSS)Timepoint: 5 years;Health economics(Out of pocket expenditure)Timepoint: Post completion of Radiotherapy;Local recurrence rate [in affected breast] (LR)Timepoint: 5 years;locoregional recurrence rate (LRR)Timepoint: 5 years;Measurement of the quality of life (QOL)Timepoint: 0,6 months and then yearly for 5 years;Overall survival (OS)Timepoint: 5 years;R0 resection rateTimepoint: Post Surgery;Residual Cancer BurdenTimepoint: Post Surgery;Sentinel Lymph node biopsy yieldTimepoint: Post SLNB;Surgeon questionnaire for ease of surgeryTimepoint: At time of discharge post Surgery | — |
Countries
India
Contacts
Public ContactRishi P Nair
All India Institute of Medical Sciences,Jodhpur
Outcome results
None listed