Prediction of pCR by Preoperative Biopsy in Breast Cancer With cCR After Neoadjuvant Chemotherapy.
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About
The purpose of this study is to evaluate the ability of preoperative biopsy to predict correctly pathologic complete response in breast cancer patients with complete clinical response after neoadjuvant chemotherapy.
Full description
Breast cancer patients who received neoadjuvant chemotherapy and is predicted to have achieved pathologic complete response (pCR) on MRI will enrolled. The enrolled patients will undergo either US-guided multiple core needle biopsy or US-guided vacuum-assisted biopsy of the tumor bed where it had been marked with an indicator (clip). The patient will undergo subsequent wide excision of the tumor bed. Histopathologic findings of the biopsy and the surgical specimen will be compared for pCR, and the ability of preoperative biopsies to predict pCR will be evaluated.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Patients
- with unilateral primary cancer pathologically confirmed before neoadjuvant chemotherapy (NAC)
- who received NAC
- with detectable lesion / clip marker on ultrasound
- with cT1-T3 tumors
- clinical and imaging complete or near-complete response on MRI
- with informed consent
Exclusion criteria
- Multifocal cancer
- Residual microcalcification
- Contralateral breast cancer
Trial design
Primary purpose
Allocation
Interventional model
Masking
40 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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