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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02670668
Recruitment Status : Unknown
Verified January 2016 by A-Yong Cao, Fudan University.
Recruitment status was:  Not yet recruiting
First Posted : February 2, 2016
Last Update Posted : February 2, 2016
Sponsor:
Information provided by (Responsible Party):
A-Yong Cao, Fudan University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Mutation analysis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mutation analysis- NACwith PCR
consisting of 50 patients undergoing NACwith pathological compete response
Other: Mutation analysis
Experimental: Mutation analysis-NAC with SD/PD.
consisting of 50 patients undergoing NAC with SD/PD
Other: Mutation analysis



Primary Outcome Measures :
  1. 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 Measures :
  1. To evaluate potential relationship between these gene mutations and NAC-response in TNBC patients [ Time Frame: Baseline ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670668


Contacts
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Contact: Ayong Cao, MD +86 13917406138 caoayong0309@sina.com

Locations
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China, Shanghai
Department of Breast Surgery, Cancer Hospital, Fudan University
Shanghai, Shanghai, China, 200032
Contact: Ayong Cao         
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Ayong Cao, MD Fudan University
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Responsible Party: A-Yong Cao, MD, Fudan University
ClinicalTrials.gov Identifier: NCT02670668    
Other Study ID Numbers: ESR-14-10562
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by A-Yong Cao, Fudan University:
BRCA1/2;Mutations;Neoadjuvant chemotherapy;TNBC
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases