Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04711109
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2021-01-13
Brief Title:
Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
BRCA-P A Randomized Double-Blind Placebo-Controlled Multi-Center International Phase 3 Study to Determine the Preventive Effect of Denosumab on Breast Cancer in Women Carrying a BRCA1 Germline Mutation
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRCA-P
Brief Summary:
This phase III trial compares denosumab to placebo for the prevention of breast cancer in women with a BRCA1 germline mutation A germline mutation is an inherited gene change which in the BRCA1 gene is associated with an increased risk of breast and other cancers Denosumab is a monoclonal antibody that is used to treat bone loss in order to reduce the risk of bone fractures in healthy people and to reduce new bone growths in cancer patients whose cancer has spread to their bones Research has shown that denosumab may also reduce the risk of developing breast cancer in women carrying a BRCA1 germline mutation
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate the reduction in the risk of any breast cancer invasive or ductal carcinoma in situ DCIS in women with germline BRCA1 mutation who are treated with denosumab compared to placebo
SECONDARY OBJECTIVES
I To determine the reduction in the risk of invasive breast cancer in women with germline BRCA1 mutation who are treated with denosumab compared to placebo
II To determine the reduction in the risk of invasive triple negative breast cancer TNBC in women with germline BRCA1 mutation who are treated with denosumab compared to placebo
III To determine the reduction in risk of ovarian fallopian and peritoneal cancers in women who have not undergone prophylactic bilateral salpingo-oophorectomy PBSO in women with germline BRCA1 mutation who are treated with denosumab compared to placebo
IV To determine the reduction in risk of other ie non-breast and nonovarian malignancies including those known to be associated with BRCA1 germline mutations in women with germline BRCA1 mutation who are treated with denosumab compared to placebo
V To determine the reduction in the risk of clinical fractures in pre- and postmenopausal women with germline BRCA1 mutation who are treated with denosumab compared to placebo
VI To compare rates of breast biopsies and rate of benign breast lesions in women with germline BRCA1 mutation who are treated with denosumab compared to placebo
OUTLINE Patients are randomized to 1 of 2 arms
ARM A Patients receive denosumab subcutaneously SC every 6 months q6m for up to 5 years in the absence of the development of breast cancer or unacceptable toxicity
ARM B Patients receive placebo SC q6m for up to 5 years in the absence of the development of breast cancer
After completion of study treatment patients are followed up every 12 months for 5 years
I To evaluate the reduction in the risk of any breast cancer invasive or ductal carcinoma in situ DCIS in women with germline BRCA1 mutation who are treated with denosumab compared to placebo
SECONDARY OBJECTIVES
I To determine the reduction in the risk of invasive breast cancer in women with germline BRCA1 mutation who are treated with denosumab compared to placebo
II To determine the reduction in the risk of invasive triple negative breast cancer TNBC in women with germline BRCA1 mutation who are treated with denosumab compared to placebo
III To determine the reduction in risk of ovarian fallopian and peritoneal cancers in women who have not undergone prophylactic bilateral salpingo-oophorectomy PBSO in women with germline BRCA1 mutation who are treated with denosumab compared to placebo
IV To determine the reduction in risk of other ie non-breast and nonovarian malignancies including those known to be associated with BRCA1 germline mutations in women with germline BRCA1 mutation who are treated with denosumab compared to placebo
V To determine the reduction in the risk of clinical fractures in pre- and postmenopausal women with germline BRCA1 mutation who are treated with denosumab compared to placebo
VI To compare rates of breast biopsies and rate of benign breast lesions in women with germline BRCA1 mutation who are treated with denosumab compared to placebo
OUTLINE Patients are randomized to 1 of 2 arms
ARM A Patients receive denosumab subcutaneously SC every 6 months q6m for up to 5 years in the absence of the development of breast cancer or unacceptable toxicity
ARM B Patients receive placebo SC q6m for up to 5 years in the absence of the development of breast cancer
After completion of study treatment patients are followed up every 12 months for 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ABCSG 50 | OTHER | Austrian Breast Colorectal Cancer Study Group | httpsreporternihgovquickSearchUG1CA189823 |
| NCI-2020-11358 | REGISTRY | None | None |
| UG1CA189823 | NIH | None | None |
| 2017-002505-35 | EUDRACT_NUMBER | None | None |