Mutation of BRCA1/2 and Other Potential Genes in Triple-negative Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02670668|
Recruitment Status : Unknown
Verified January 2016 by A-Yong Cao, Fudan University.
Recruitment status was: Not yet recruiting
First Posted : February 2, 2016
Last Update Posted : February 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: Mutation analysis||Not Applicable|
This is single centre，exploratory，parallel and retrospective study to analysis the mutation and expression of tBRCA1/2 and other potential genes in triple-negative breast cancer. Patients received neoadjuvant chemotherapy with paclitaxel and carboplation are enrolled in this study. The participants are required to have clinical stage II or III breast cancer with a clinical or radiographically measurable residual tumor after core biopsy. We will enroll the patients of pCR or SD/PD, which achieved after complete NAC. Every group will enroll 50 patients. This study is to identify relationship between different gene mutations and expression, which may be targeted with currently available investigational drugs, and chemo-response.
Patients who will fulfil all inclusion/exclusion criteria. We conducted a retrospective chart review of the 100 patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|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|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
Experimental: Mutation analysis- NACwith PCR
consisting of 50 patients undergoing NACwith pathological compete response
Other: Mutation analysis
Experimental: Mutation analysis-NAC with SD/PD.
consisting of 50 patients undergoing NAC with SD/PD
Other: Mutation analysis
- 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 [ Time Frame: Baseline ]
- To evaluate potential relationship between these gene mutations and NAC-response in TNBC patients [ Time Frame: Baseline ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670668
|Contact: Ayong Cao, MD||+86 email@example.com|
|Department of Breast Surgery, Cancer Hospital, Fudan University|
|Shanghai, Shanghai, China, 200032|
|Contact: Ayong Cao|
|Principal Investigator:||Ayong Cao, MD||Fudan University|