Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically proved breast carcinoma 2. All LABC/LOBC patients undergoing Neoadjuvant systemic Therapy. 3.From 18 years to 65 years 4. Written informed consent 5. ECOG-1 6. 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 history of excision biopsy/other cancer. 4. Drug Addication/present substance abuse 5. History of allergy to Inj. Lignocaine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint- 1.Event free survival Timepoint: 7 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint- 1. Overall survival- key secondary endpoint 2. Estimated pCR rates at interim analysis. 3. Evaluation of ctDNA levels 4. Evaluation of incidenence of CINV in both the arms Timepoint: 7 years | — |
Countries
India
Contacts
ACTREC