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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02670668
• Other study ID #: ESR-14-10562
• Status: Not yet recruiting
• Phase: N/A
• First received: January 28, 2016
• Last updated: January 28, 2016
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: January 2016
• Source: Fudan University
• Contact: Ayong Cao, MD
• Phone: +86 13917406138
• Email: caoayong0309[@]sina.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Triple Negative Breast Neoplasms

Intervention

Other:
• Mutation analysis

Locations

Country	Name	City	State
China	Department of Breast Surgery, Cancer Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

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