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NCT01934478 Clinical Trial

Radiotherapy Alternates Human Epidermal Growth Factor 2 (Her2) Expression in Human Breast Cancer

Human Epidermal Growth Factor 2 Negative Carcinoma of Breast Clinical Trial

Official title:
Study on Human Epidermal Growth Factor 2 (Her2) Expression Changes in Human Breast Cancer After Radiotherapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01934478
Other study ID # QCH20130823-2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2013
Est. completion date December 30, 2022

Study information
Verified date March 2023
Source Qingdao Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Based on fundamental study （in Vitro and in Vivo, Pro. Jianjian Li）， Her2 expression would be changed from negative to positive by cancer irradiation with liner-accelerator at dose 6GY or up. The propose of this study is to reveal the irradiation result on Her2 expression in human breast cancer.

Recruitment information / eligibility
Status Completed
Enrollment 5
Est. completion date December 30, 2022
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - histological confirmed advanced breast cancer - cancer sample can be obtained by fine needle biopsy - IHC and FISH confirmed Her2 negative - radiotherapy indication for local residual cancer Exclusion Criteria: - no radiotherapy indication - patient refuse

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Qingdao Central Hospital, Qingdao Cancer Hospital Qingdao Shandong

Sponsors (1)
Lead Sponsor Collaborator
Qingdao Central Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Her2 changes during radiotherapy biopsy is obtained by fine needle biopsy,Her2 is checked by Immunohistochemistry (IHC) and Fluorescence in situ hybridization (FISH). every week up to 6 weeks
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