Clinical trial NCT02670668: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: BRCA1/2;Mutations;Neoadjuvant chemotherapy;TNBC
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2016-02-02
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: 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
timeFrame: Baseline
Secondary outcomes:
measure: To evaluate potential relationship between these gene mutations and NAC-response in TNBC patients
timeFrame: Baseline
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Breast Surgery, Cancer Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Ayong Cao, MD
role: PRINCIPAL_INVESTIGATOR
References: