Ignite Creation Date:
2024-05-06 @ 4:11 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04906395
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2021-05-12
Brief Title:
Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer
Sponsor:
Tolmar Inc
Organization:
Tolmar Inc
Study Overview
Official Title:
Phase 3Single ArmOpen-Label Study Evaluating Ovarian Suppression Following 3 Month Leuprolide Acetate For Injectable Suspension TOL2506 in Combination With Endocrine Therapy in Premenopausal Subjects With Hormone-Receptor-Positive HRHuman Epidermal Growth Factor Receptor 2 HER2-Negative Breast Cancer
Status:
RECRUITING
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:
OVELIA
Brief Summary:
This is a phase 3 single arm open-label study evaluating the effectiveness of TOL2506 to suppress ovarian function in premenopausal women with HR HER2-negative breast cancer The study will also aim to assess the safety of TOL2506 in men with HR HER2-negative breast cancer The Screening Period will be conducted in two parts 1 an abbreviated initial screening where premenopausal status will be determined prior to neoadjuvant or adjuvant chemotherapy if planned and 2 the full screening assessment conducted after neoadjuvant or adjuvant chemotherapy or for subjects who enter the study without having received chemotherapy Following the Screening Period eligible subjects will enter into the 48 week Treatment Period in 1 of 2 groups those who will receive tamoxifen concurrently with TOL2506 or those who will initiate therapy with an AI letrozole anastrozole or exemestane beginning 6 weeks after the first administration of TOL2506 upon confirmation that estradiol E2 levels of 20 pgmL testosterone levels 50 ngdL in males have been achieved After Week 12 subjects will be allowed to switch from receiving an AI to receiving tamoxifen or from tamoxifen to AI at the discretion of the Investigator However a switch is not permitted 28 days prior to a dosing visit eg Week 24 36 and 48 where a pre-dose blood sample for PK and PD analysis will be drawn At the end of the Treatment Period upon completion of the End of Study Visit Visit 9 Week 48 subjects may be eligible to participate in a Safety Extension Study under a separate Protocol
Detailed Description:
None
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