Ignite Creation Date:
2024-05-06 @ 4:23 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04960839
Status:
RECRUITING
Last Update Posted:
2021-07-14
First Post:
2020-05-12
Brief Title:
Prophylactic Irradiation to the Contralateral Breast for BCAs Patients
Sponsor:
Second Affiliated Hospital School of Medicine Zhejiang University
Organization:
Second Affiliated Hospital School of Medicine Zhejiang University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PICB
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None