RecruitingNot ApplicableNCT04960839

Prophylactic Irradiation to the Contralateral Breast for BCAs Patients

Phase II Multicenter Clinical Trial of Prophylactic Irradiation to the Contralateral Breast for Breast Cancer Patients With BRCA1, BRCA2 and PALB2 Deleterious Mutation


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

323 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 30 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving preventive radiation to the opposite (unaffected) breast can reduce the risk of breast cancer developing there in women with a high genetic risk. **You may be eligible if...** - You are a woman between 30 and 70 years old - You have been diagnosed with stage 0 through III breast cancer and had surgery (lumpectomy or mastectomy) within the past year - You carry a harmful gene mutation in BRCA1, BRCA2, or PALB2 - You have no contraindications to radiation therapy - You consent to receiving preventive radiation to the opposite breast **You may NOT be eligible if...** - You have a condition that makes radiation unsafe - You do not carry the BRCA1, BRCA2, or PALB2 gene mutations - You have stage IV (metastatic) breast cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONProphylactic 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

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NCT04960839


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