Mutation of BRCA1/2 and Other Potential Genes in Triple-negative Breast Cancer

Not Applicable

• Conditions: Breast Cancer
• Interventions: Other: Mutation analysis

• Registration Number: NCT02670668
• Lead Sponsor: Fudan University

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.

Detailed Description

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 Timeline

• Status Verified: 2016-01
• Study Start: 2016-01
• Study First Submitted: 2016-01-28
• Study First Submitted QC: 2016-01-28
• Last Update Submitted: 2016-01-28
• Study First Posted: 2016-02-02
• Last Update Posted: 2016-02-02
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mutation analysis- NACwith PCR	Mutation analysis	consisting of 50 patients undergoing NACwith pathological compete response
Mutation analysis-NAC with SD/PD.	Mutation analysis	consisting of 50 patients undergoing NAC with SD/PD

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
To evaluate potential relationship between these gene mutations and NAC-response in TNBC patients	Baseline

Trial Locations

Locations (1)

Department of Breast Surgery, Cancer Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China