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NCT03188393 Clinical Trial

Assessing the Accuracy of Tumor Biopsies After Chemotherapy to Determine if Patients Can Avoid Breast Surgery

Stage IIIA Breast Cancer Clinical Trial

Official title:
A Phase II Trial Assessing the Accuracy of Tumor Bed Biopsies in Predicting Pathologic Response in Patients With Clinical/Radiologic Complete Response After Neoadjuvant Chemotherapy in Order to Explore the Feasibility of Breast Conserving Treatment Without Surgery

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT03188393
Other study ID # NRG-BR005
Secondary ID NCI-2016-01825NR
Status Suspended
Phase Phase 2
First received
Last updated
Start date April 13, 2017
Est. completion date November 30, 2024

Study information
Verified date May 2024
Source NRG Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II trial studies how well biopsy of breast after chemotherapy works in predicting pathologic response in patients with stage II-IIIA breast cancer undergoing breast conserving surgery. Tumor tissue collected from biopsy before surgery may help to check if chemotherapy destroyed the breast cancer cells and may be compared to the tumor removed during surgery to check if they are the same.

Description:

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Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Biopsy of Breast
Undergo stereotactic biopsy
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Sponsors (2)
Lead Sponsor Collaborator
NRG Oncology National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Other Molecular makers from tumor and blood samples Analysis to assess the association of molecular markers with response to neoadjuvant therapy. Up to 18 months
Primary Proportion of patients with pCR The proportion of tumor bed biopsies that are negative among those who are shown to have pCR at surgery will be determined. The point estimate and 95% confidence interval will be calculated. Up to 18 months
Secondary Improvement of negative predictive value Analysis will be performed to assess the improvement in the negative predictive value of the trimodality imaging algorithm when the results of tumor bed biopsy are added. Up to 18 months
Secondary Incidence of adverse events associated with tumor bed biopsy Descriptive analysis will be performed to determine the frequencies of adverse events associated with tumor bed biopsy. Up to 18 months
Secondary Number of needle cores performed Descriptive analysis will be performed to determine the distribution of the number of needle cores performed and the proportion of clips retrieved. Up to 18 months
Secondary Proportion of clips retrieved Descriptive analysis will be performed. Up to 18 months
Secondary Residual cancer burden score Descriptive analysis will be performed to determine the distribution of residual cancer burden score. Up to 18 months
Secondary Trimodality imaging algorithm +/- biopsy as a predictor of pCR Analysis will be performed to assess the improvement in the negative predictive value of the trimodality imaging algorithm when the results of tumor bed biopsy are added. Up to18 months
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