Health Condition 1: null- Breast cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients willing to provide informed consent 2. Patients with newly diagnosed non metastatic breast cancer who have no clinically or radiologically demonstrable disease following neoadjuvant chemotherapy as seen on a mammogram and ultrasound of the breast.
Exclusion criteria
Exclusion criteria: 1. Patients with prior history of any malignancy 2. Patients with excision biopsy of the breast primary 3. Patients undergoing upfront surgery 4. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| False negative rate of multiple core biopsies in predicting pathological complete responseTimepoint: 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Accuracy, positive and negative predictive value of multiple core biopsies in predicting pathological complete responseTimepoint: 18 months;Exploratory analysis between the multiple core biopsies,pathological complete response in the breast and pathological complete response in the axillaTimepoint: 18 months;Planned subgroup analysis for the false negative rate in triple negative and HER2 positive breast cancersTimepoint: 18 months | — |
Countries
India
Contacts
Basavatarakam Indo American Cancer Hospital and Research Institute