Ignite Creation Date:
2024-05-06 @ 1:11 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03956654
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2019-04-12
Brief Title:
A Phase IV Study to Collect Data on the Efficacy and Safety of RIBociclib in Older Women With Breastcancer
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
A Phase IV Study to Collect Data on the Efficacy and Safety of RIBociclib With Letrozole in Older Women 70 Years With HR and HER2- Advanced Breast Cancer aBC With no Prior Systemic Therapy for Advanced Disease
Status:
COMPLETED
Status Verified Date:
2024-08
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:
RibOB
Brief Summary:
The RibOB study is a prospective open lable single arm trial which will evaluate the clinical efficacy overall safety and tolerability of ribociclib in combination with letrozole in older women 70 years with HRHER2- aBC and no prior hormonal treatment for advanced disease as per approved indication
Detailed Description:
The RibOB study is an observational prospective open lable single arm phase IV trial which will evaluate the clinical efficacy overall safety and tolerability of ribociclib in combination with letrozole in older women 70 years with HR HER2- advanced breast cancer and no prior hormonal treatment for advanced disease as per the indication approved by the European Medicines Authority EMA and as made available by Belgian national authorities in the national health care system A total of maximum 150 patients will be enrolled for treatment with Letrozole 25 mg once daily ribociclib 600 mg day 1 to 21 in a 28 day cycle which will continue until disease progression intolerable toxicity or patientphysician decision to withdraw During the study patients will be continuously evaluated for disease progression as per national standard of care approximately every 12 weeks radiologically for safety and for quality of life and geriatric assessment components including functional status with QoL assessment and CGA at 3 months - 2 weeks and at 1 year -2 weeks
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