Ignite Creation Date:
2024-05-06 @ 7:46 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02592746
Status:
UNKNOWN
Last Update Posted:
2019-04-08
First Post:
2015-10-29
Brief Title:
A Study of Palbociclib With Exemestane Plus GnRH Versus Capecitabine in Premenopausal Women With HR MBC
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
A Phase II Randomized Study of Palbociclib in Combination With Exemestane Plus GnRH Versus Capecitabine in Premenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2019-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
None
Brief Summary:
Despite recent advances for the treatment of post-menopausal hormone receptor-positive BC in the last decade there was no major improvement of hormonal therapy specifically for premenopausal metastatic breast cancer The median age of breast cancer is much younger and the proportion of young breast cancer YBC patients less than 40 including premenopausal women is much higher in Asia including Korea
Capecitabine the comparator in this trial is an orally-administered fluoropyrimidine derivative and has shown high efficacy and low toxicity in metastatic breast cancer patients Palbociclib is a CDK46 inhibitors in combination with endocrine therapy showed marked advance in hormone receptor-positive MBC in the post-menopausal setting After a median follow-up of 165 months preliminary results from Part 1 of this Phase 2 trial suggest that the combination of PD-0332991 with letrozole is superior to letrozole alone and improved objective response and disease control rates 52 vs 32 and 76 vs 47 respectively in patients treated with the combination These remarkable results may contribute to have much benefit with endocrine therapy for premenopausal women Most importantly recent PALOMA-3 trial revealed superior results of adding palbociclib to fulvestrant median PFS 92 vs 38 months P0001
Based on these rational backgrounds the purpose of this phase II study is to assess the safety and the clinical anti-tumor activity of exemestane plus goserelin acetate in combination with palbociclib vs capecitabine in premenopausal hormone receptor-positive advanced breast cancer patients
Capecitabine the comparator in this trial is an orally-administered fluoropyrimidine derivative and has shown high efficacy and low toxicity in metastatic breast cancer patients Palbociclib is a CDK46 inhibitors in combination with endocrine therapy showed marked advance in hormone receptor-positive MBC in the post-menopausal setting After a median follow-up of 165 months preliminary results from Part 1 of this Phase 2 trial suggest that the combination of PD-0332991 with letrozole is superior to letrozole alone and improved objective response and disease control rates 52 vs 32 and 76 vs 47 respectively in patients treated with the combination These remarkable results may contribute to have much benefit with endocrine therapy for premenopausal women Most importantly recent PALOMA-3 trial revealed superior results of adding palbociclib to fulvestrant median PFS 92 vs 38 months P0001
Based on these rational backgrounds the purpose of this phase II study is to assess the safety and the clinical anti-tumor activity of exemestane plus goserelin acetate in combination with palbociclib vs capecitabine in premenopausal hormone receptor-positive advanced breast cancer patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None