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

Fudan University

Status: Unknown

Conditions: Breast Cancer

Treatments: Other: Mutation analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT02670668

ESR-14-10562

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Mutation analysis- NACwith PCR

Experimental group

Description:

consisting of 50 patients undergoing NACwith pathological compete response

Treatment:

Other: Mutation analysis

Mutation analysis-NAC with SD/PD.

Experimental group

Description:

consisting of 50 patients undergoing NAC with SD/PD

Treatment:

Other: Mutation analysis