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Role of core biopsy to predict complete response in the breast after preoperative chemotherapy - CRBr study

Accuracy of core biopsy in predicting pathological complete response in the breast in patients with complete clinical and radiological response post chemotherapy (CRBr) - A feasibility study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/01/011122
Enrollment
100
Registered
2018-01-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Breast cancer

Interventions

Intervention1: Core biopsy: An ultrasound guided core biopsy will be done in patients having complete clinical and radiological response to chemotherapy and this will be compared to the final histopat

Sponsors

Basavatarakam Indo American Cancer Hospital Research Institute
Lead Sponsor

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

MeasureTime frame
False negative rate of multiple core biopsies in predicting pathological complete responseTimepoint: 18 months

Secondary

MeasureTime 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

Public ContactDr Nisha Hariharan

Basavatarakam Indo American Cancer Hospital and Research Institute

dr.nishahariharan@gmail.com09769659266

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 22, 2026