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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02670668
Enrollment
100
Registered
2016-02-02
Start date
2016-01-31
Completion date
2018-12-31
Last updated
2016-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

BRCA1/2;Mutations;Neoadjuvant chemotherapy;TNBC

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.

Interventions

OTHERMutation analysis

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Gene mutation prevalence of tBRCA1/2, HRR, or other chemo-response related genes in TNBC patients between pCR and SD/PD, which achieved after NACBaseline

Secondary

MeasureTime frame
To evaluate potential relationship between these gene mutations and NAC-response in TNBC patientsBaseline

Countries

China

Contacts

Primary ContactAyong Cao, MD
caoayong0309@sina.com+86 13917406138

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026