Ignite Creation Date:
2024-05-06 @ 12:59 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03906669
Status:
RECRUITING
Last Update Posted:
2023-11-22
First Post:
2018-09-18
Brief Title:
A Window of Opportunity Study of Pre-operative Endocrine Therapy With and Without Prometrium in Postmenopausal Women With Early Stage Breast Hormone Receptor Positive HR Human Epidermal Receptor 2 Negative HER2- Breast Cancer
Sponsor:
St Vincents Hospital
Organization:
St Vincents Hospital
Study Overview
Official Title:
A Window of Opportunity Study of Endocrine Therapy With and Without Prometrium in Postmenopausal Women With Early Stage Hormone Receptor-positive Breast Cancer
Status:
RECRUITING
Status Verified Date:
2023-11
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:
WinPro
Brief Summary:
A phase II randomised open label study of pre-operative endocrine therapy with without prometrium in postmenopausal women with early stage breast hormone receptor positive HR human epidermal receptor 2 negative HER2- breast cancer
Detailed Description:
There is bidirectional interplay between the progesterone receptor PR and oestrogen receptor ER in human breast cancers There is evidence for a reprogramming of ER chromatin binding sites with 470 genes differentially regulated by dual treatment with estrogen plus progestogen compared to estrogen alone in breast cancer cell lines Functionally there was an additive anti-cancer effect with the addition of natural progesterone to endocrine therapy in preclinical breast cancer models
This is a phase II multi-site randomised open-label three-arm study in 200 postmenopausal women with early-stage ER PR HER2-negative breast cancer Eligible patients will be randomised 111 to receive 14 days of intervention with either letrozole 25mg PO daily arm 1 letrozole 25mg prometrium 300mg PO daily arm 2 or tamoxifen 20mg prometrium 300mg PO daily arm 3 between diagnosis of breast cancer and definitive surgery
This is a phase II multi-site randomised open-label three-arm study in 200 postmenopausal women with early-stage ER PR HER2-negative breast cancer Eligible patients will be randomised 111 to receive 14 days of intervention with either letrozole 25mg PO daily arm 1 letrozole 25mg prometrium 300mg PO daily arm 2 or tamoxifen 20mg prometrium 300mg PO daily arm 3 between diagnosis of breast cancer and definitive surgery
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