Prophylactic Irradiation to the Contralateral Breast for BCAs Patients

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.

Conditions

• Breast Cancer

Interventions

RADIATION

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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  lead OTHER

Principal Investigators

• Peifen Fu, M.D. · Department of Breast Surgery, The First Affiliated Hospital, College of Medicine, Zhejiang University

• Wenjun Chen, M.D. · Department of Surgical Oncology, Sir Run Run Shaw Hospital, Zhejiang University

• Kejin Wu, M.D. · Department of Breast Surgery, Obsterics and Gynecology Hospital of Fudan University

• Xiaowen Ding, M.D. · Department of Breast Surgery, Cancer Hospital of University of Chinese Academy of Sciences

• Zhengkui Sun · Department of Breast Surgery, Jiangxi Provincial Cancer Hospital

• Mikael Hartman · Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore

• Yiding Chen · Department of Breast Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine

• Jiaojiao Zhou · Departmen of Breast Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine

• Kun Zhang · Departmen of Breast Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine

• Wenhong Xu · Departmen of Radiology, The Second Affiliated Hospital, Zhejiang University School of Medicine

• Zhibing Wu · Department of Oncology, Zhejiang Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-01

Primary Completion

2029-12-01

Completion

2029-12-01

Countries

• China
• Singapore

Study Locations