Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05879926
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2023-05-19
Brief Title:
Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1 ER-PositiveHER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25
Sponsor:
NRG Oncology
Organization:
NRG Oncology
Study Overview
Official Title:
A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1 ER-PositiveHER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 OFSET
Status:
RECRUITING
Status Verified Date:
2024-10
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:
OFSET
Brief Summary:
This Phase III Trial will determine whether adjuvant chemotherapy ACT added to ovarian function suppression OFS plus endocrine therapy ET is superior to OFS plus ET in improving invasive breast cancer-free survival IBCFS among premenopausal early- stage breast cancer EBC patients with estrogen receptor ER-positive HER2-negative tumors and 21-gene recurrence score RS between 16-25 for pN0 patients and 0-25 for pN1 patients
Detailed Description:
Younger age at diagnosis is an adverse prognostic factor in early breast cancer women who are less than 35 years of age at diagnosis are more likely to die from their disease than their older counterparts following standard treatments There remains a pressing need for advancements in therapeutic options for this patient population One increasingly utilized option is ovarian suppression which was first reported as treatment for advanced breast cancer in 1896 and has been examined in a multitude of clinical trials over the past century As chemotherapeutic options became more commonplace for breast cancer therapy however the role of ovarian suppression became uncertain
In the pre-genomic era several studies evaluated the role of ovarian suppression compared to chemotherapy with conflicting results These studies either looked at ovarian suppression alone or at tamoxifen compared to chemotherapy A meta-analysis examining LHRH-agonists luteinizing hormone-releasing hormone in the Early Breast Cancer Overview group LHRH-agonists in Early Breast Cancer Overview group 2007 showed that when LHRH-agonists were added to tamoxifen chemotherapy or both there was a 127 reduction in the risk of recurrence and a 151 reduction in the risk of death When compared to chemotherapy LHRH-agonists appeared to be equally as effective especially if patients were less than 40 years of age These older studies conducted in the pre-taxaneanthracycline era typically used CMF cyclophosphamide methotrexate and fluorouracil chemotherapy and were designed prior to the use of genomic assays
In the pre-genomic era several studies evaluated the role of ovarian suppression compared to chemotherapy with conflicting results These studies either looked at ovarian suppression alone or at tamoxifen compared to chemotherapy A meta-analysis examining LHRH-agonists luteinizing hormone-releasing hormone in the Early Breast Cancer Overview group LHRH-agonists in Early Breast Cancer Overview group 2007 showed that when LHRH-agonists were added to tamoxifen chemotherapy or both there was a 127 reduction in the risk of recurrence and a 151 reduction in the risk of death When compared to chemotherapy LHRH-agonists appeared to be equally as effective especially if patients were less than 40 years of age These older studies conducted in the pre-taxaneanthracycline era typically used CMF cyclophosphamide methotrexate and fluorouracil chemotherapy and were designed prior to the use of genomic assays
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5U10CA180868-07 | NIH | None | None |
| NCI-2023-04529 | REGISTRY | CTRP | httpsreporternihgovquickSearch5U10CA180868-07 |