Ignite Creation Date:
2024-05-06 @ 5:53 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05467891
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-05
First Post:
2022-06-28
Brief Title:
Ribociclib And Endocrine Treatment of Physicians Choice for Locoregional Recurrent Resected Hormone Receptor Positive HER2 Negative Breast Cancer
Sponsor:
Oana Danciu
Organization:
Hoosier Cancer Research Network
Study Overview
Official Title:
A Phase II Study of Ribociclib And Endocrine Treatment of Physicians Choice for Locoregional Recurrent Resected Hormone Receptor Positive HER2 Negative Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
RaPhLRR
Brief Summary:
This is an open label multicenter single arm phase II study to evaluate the efficacy and safety of ribociclib and ET in patients with locoregional recurrence of HR-positive HER2-negative breast cancer
Detailed Description:
Collection of Correlative Samples at First Recurrence Stage I consent If feasible optional correlative blood and fresh tissue will be collected during surgical excision of their 1st recurrence Patients should then complete radiation therapy if that is indicated Enrollment to the Treatment Phase will occur within 6 months of the last local treatment surgery or radiation treatment whichever occurred last
Study Treatment Stage II main consent
Treatment includes
1 Ribociclib
Oral ribociclib at a dose of 600 mg daily for 21 days out of a 28-day cycle Ribociclib will be used in combination with ET per physician choice
2 Physicians Choice Endocrine Therapy
ET consists of one of the following
Intramuscular fulvestrant
Oral anastrozole
Oral letrozole
Oral exemestane
Concomitant use with tamoxifen is not allowed
Ribociclib administration is planned for 36 months and ET administration is planned for 60 months
Study Treatment Stage II main consent
Treatment includes
1 Ribociclib
Oral ribociclib at a dose of 600 mg daily for 21 days out of a 28-day cycle Ribociclib will be used in combination with ET per physician choice
2 Physicians Choice Endocrine Therapy
ET consists of one of the following
Intramuscular fulvestrant
Oral anastrozole
Oral letrozole
Oral exemestane
Concomitant use with tamoxifen is not allowed
Ribociclib administration is planned for 36 months and ET administration is planned for 60 months
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?:
True
Is an FDA AA801 Violation?:
None