Breast Cancer Clinical Trial
Official title:
Single Centre,Exploratory,Parallel and Retrospective Study to Analysis the Mutation and Expression of BRCA1/2 and Other Potential Genes in Triple-negative Breast Cancer
The study is to determine the prevalence of potential chemo-response related genes mutation in TNBC patients between pCR and SD/PD group, which achieved after NAC; and to evaluate potential relationship between these gene mutations and NAC-response in TNBC patients.Based on the results,we can further characterize TNBC from a phenotypical and molecular perspective, in order to identify potential new target agents and to individualize the treatment.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: Patients receiving neoadjuvant chemotherapy with paclitaxel and carboplation are enrolled in this study. - (1) histologically confirmed mainly invasive breast carcinoma - (2) a unilateral and non-inflammatory tumors - (3) status of ER, PR and HER-2 are available and negative - (4) The participants are required to have clinical stage II or III breast cancer with a clinical or radiographically measurable residual tumor after core biopsy. - (5)patients had pathological evaluation after NAC - (6) the pathologic tissues are available for immunohistochemistry and next generation sequencing Exclusion Criteria: - (1) carcinoma in situ - (2) received less than 4 cycles neoadjuvant chemotherapy |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
China | Department of Breast Surgery, Cancer Hospital, Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Fudan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gene mutation prevalence of tBRCA1/2, HRR, or other chemo-response related genes in TNBC patients between pCR and SD/PD, which achieved after NAC | Baseline | No | |
Secondary | To evaluate potential relationship between these gene mutations and NAC-response in TNBC patients | Baseline | No |
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