Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Chemotherapy First: 1) To demonstrate an improvement in disease free survival in the â??Surgery first ? arm when compared to â??Preoperative chemotherapy arm ? in triple negative and HE
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1.Histologically proved breast carcinoma 2.Triple negative(ER, PgR, HER2-neu) and HER2-neu positive (ER/PgR +/-) 3.T1-2 (excluding T1a), N0-1 (non-metastatic) 4. > 18 years 5.ECOG 0-1 6.Written informed consent 7.Fit for surgery or chemotherapy
Exclusion criteria
Exclusion criteria: 1.Pregnant, lactating women 2.Previous h/o breast or any other non-skin malignancy 3.Previous treatment for excision biopsy/other cancer. 4.History of allergy to Inj. Lignocaine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival Overall survival Timepoint: until 10 years | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Breast cancer specific survival â?¢Local recurrence (IBTR) â?¢Regional recurrence â?¢Evaluation of pathological complete response in the pre-operative chemotherapy arm â?¢Cosmetic assessment after breast conservation surgery (BCCT-Core software) â?¢Evaluation of margin positive rate in the 2 arms â?¢QOL assessment (BREAST-Q) Timepoint: until 2 years | — |
Countries
India
Contacts
Public ContactDr Shalaka Joshi
Tata Memorial Centre
Outcome results
None listed