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Spots Global Cancer Trial Database for Prophylactic Irradiation to the Contralateral Breast for BCAs Patients

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Trial Identification

Brief Title: Prophylactic Irradiation to the Contralateral Breast for BCAs Patients

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

Study ID: NCT04960839

Conditions

Breast Cancer

Study Description

Brief 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.

Detailed Description: Breast cancer is the most common cancer in women worldwide, with high mortality. In the US in 2018, the number of estimated new cases of breast cancer accounted for 30% of all the new cancer cases in women, while the estimated deaths of breast cancer accounted for 14% of all new cancer deaths. In Chinese females, the most commonly diagnosed cancer was breast cancer, accounting for 19% of total cases. And breast cancer was the main 5 most common causes of cancer-related deaths in China. About 5% to 10% of breast cancers are hereditary. Most inherited cases of breast cancer are associated with germline mutations in two genes: BRCA1 (BRCA1 DNA repair associated) and BRCA2 (BRCA2 DNA repair associated). The cumulative breast cancer risk for BRCA1 or BRCA2 mutation carriers at age 70 years reached as high as 50% in US population and 37% in Chinese population. Benefiting from the next generation sequencing technology, more inherited gene mutations were discovered. Among these new discovered susceptibility genes, PALB2 (Partner and localizer of BRCA2) was associated with high increased risks of breast cancer in both Chinese and US population. 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. For contralateral breast cancer in BRCA mutation carriers, the cumulative risk for 10 years after breast cancer diagnosis was as high as 25% and for 20 years reached to 40%, as compared 3% and 12% respectively in non-carriers. Contralateral prophylactic mastectomy was usually recommended to the breast cancer patients with BRCA mutation, as it can absolutely reduce the risk of contralateral primary cancer. 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

Minimum Age: 30 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Department of Breast Surgery, Jiangxi Provincial Cancer Hospital, Jiangxi, Jiangxi, China

Department of Breast Surgery, Obestrics and Gynecology Hospital of Fudan University, Shanghai, Shanghai, 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

Contact Details

Name: Peifen Fu, M.D.

Affiliation: Department of Breast Surgery, The First Affiliated Hospital, College of Medicine, Zhejiang University

Role: PRINCIPAL_INVESTIGATOR

Name: Wenjun Chen, M.D.

Affiliation: Department of Surgical Oncology, Sir Run Run Shaw Hospital, Zhejiang University

Role: PRINCIPAL_INVESTIGATOR

Name: Kejin Wu, M.D.

Affiliation: Department of Breast Surgery, Obsterics and Gynecology Hospital of Fudan University

Role: PRINCIPAL_INVESTIGATOR

Name: Xiaowen Ding, M.D.

Affiliation: Department of Breast Surgery, Cancer Hospital of University of Chinese Academy of Sciences

Role: PRINCIPAL_INVESTIGATOR

Name: Zhengkui Sun

Affiliation: Department of Breast Surgery, Jiangxi Provincial Cancer Hospital

Role: PRINCIPAL_INVESTIGATOR

Name: Mikael Hartman

Affiliation: Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore

Role: PRINCIPAL_INVESTIGATOR

Name: Yiding Chen

Affiliation: Department of Breast Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine

Role: PRINCIPAL_INVESTIGATOR

Name: Jiaojiao Zhou

Affiliation: Departmen of Breast Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine

Role: PRINCIPAL_INVESTIGATOR

Name: Kun Zhang

Affiliation: Departmen of Breast Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine

Role: PRINCIPAL_INVESTIGATOR

Name: Wenhong Xu

Affiliation: Departmen of Radiology, The Second Affiliated Hospital, Zhejiang University School of Medicine

Role: PRINCIPAL_INVESTIGATOR

Name: Zhibing Wu

Affiliation: Department of Oncology, Zhejiang Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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