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Prophylactic Irradiation to the Contralateral Breast for BCAs Patients
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Summary
Breast cancer is the most common cancer in women worldwide, with high mortality. About 5% to 10% of breast cancers are hereditary. Most inherited cases of breast cancer are associated with germline mutations in genes, such as BRCA1, BRCA2 and PALB2. The cumulative breast cancer risk for BRCA1, BRCA2 or PALB2 mutation carriers was high. Besides the increased breast cancer risk for the inherited mutation carriers, the risk of subsequent contralateral breast cancer for the mutation carriers with breast cancer was also significantly increased. Contralateral prophylactic mastectomy was usually recommended to the breast cancer patients with BRCA mutation. However, many breast cancer patients refused the contralateral prophylactic mastectomy, due to the surgical injury, potential surgical complications, deleteriously affected body image and sexuality. Solid evidence validated that radiotherapy after surgery resulted in a reduced local recurrence for three times lower than surgery alone. It is thought that radiation would eliminate the microscopic tumors which may already exist in the breast. Thus, we proposed that for the breast cancer patients with BRCA1, BRCA2 or PALB2 deleterious germline mutations, prophylactic irradiation to the contralateral breast may reduce the risk of subsequent contralateral breast cancer. And we would like to further compare the effect of prophylactic irradiation to the published data from traditional prophylactic contralateral mastectomy.
Official title: Phase II Multicenter Clinical Trial of Prophylactic Irradiation to the Contralateral Breast for Breast Cancer Patients With BRCA1, BRCA2 and PALB2 Deleterious Mutation
Key Details
Gender
FEMALE
Age Range
30 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
323
Start Date
2023-01-01
Completion Date
2029-12-01
Last Updated
2021-07-14
Healthy Volunteers
No
Conditions
Interventions
Prophylactic contralateral breast irradiation
The whole contralateral breast will be irradiated once daily, 5 days a week, for 5-6 weeks, using 1.8-2 Gy/fx to a total dose of 45-50 Gy.
Locations (8)
Department of Breast Surgery, Jiangxi Provincial Cancer Hospital
Jiangxi, Jiangxi, China
Department of Breast Surgery, Obestrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Department of Breast Surgery, Cancer Hospital of University of Chinese Academy of Sciences
Hangzhou, Zhejiang, China
Department of Breast Surgery, the First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Department of Breast Surgery, the Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Department of Surgical Oncology, Sir Run Run Shaw Hospital, Zhejiang University
Hangzhou, Zhejiang, China
Department of Oncology, Zhejiang Hospital
Hangzhou, Zhejiang, China
Department of Breast Surgery, Yong Loo Lin School of Medicine, National University of Singapore
Singapore, Singapore