Mutation of BRCA1/2 and Other Potential Genes in Triple-negative Breast Cancer
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
1 other identifier
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Jan 2016
Typical duration for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 28, 2016
CompletedFirst Posted
Study publicly available on registry
February 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedFebruary 2, 2016
January 1, 2016
1.9 years
January 28, 2016
January 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
To evaluate potential relationship between these gene mutations and NAC-response in TNBC patients
Baseline
Study Arms (2)
Mutation analysis- NACwith PCR
EXPERIMENTALconsisting of 50 patients undergoing NACwith pathological compete response
Mutation analysis-NAC with SD/PD.
EXPERIMENTALconsisting of 50 patients undergoing NAC with SD/PD
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- (1) carcinoma in situ
- (2) received less than 4 cycles neoadjuvant chemotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Department of Breast Surgery, Cancer Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ayong Cao, MD
Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
January 28, 2016
First Posted
February 2, 2016
Study Start
January 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2018
Last Updated
February 2, 2016
Record last verified: 2016-01