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

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Mutation analysis

About this trial

This is an interventional basic science trial for Breast Cancer focused on measuring BRCA1/2;Mutations;Neoadjuvant chemotherapy;TNBC

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Department of Breast Surgery, Cancer Hospital, Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Mutation analysis- NACwith PCR

Mutation analysis-NAC with SD/PD.

Arm Description

consisting of 50 patients undergoing NACwith pathological compete response

consisting of 50 patients undergoing NAC with SD/PD

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To evaluate potential relationship between these gene mutations and NAC-response in TNBC patients

Full Information

NCT ID

NCT02670668

First Posted

January 28, 2016

Last Updated

January 28, 2016

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT02670668

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

BRCA1/2;Mutations;Neoadjuvant chemotherapy;TNBC

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mutation analysis- NACwith PCR

Arm Type

Experimental

Arm Description

consisting of 50 patients undergoing NACwith pathological compete response

Arm Title

Mutation analysis-NAC with SD/PD.

Arm Type

Experimental

Arm Description

consisting of 50 patients undergoing NAC with SD/PD

Intervention Type

Other

Intervention Name(s)

Mutation analysis

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

To evaluate potential relationship between these gene mutations and NAC-response in TNBC patients

Time Frame

Baseline

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ayong Cao, MD

Phone

+86 13917406138

caoayong0309@sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ayong Cao, MD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Breast Surgery, Cancer Hospital, Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ayong Cao

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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