Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer (OVELIA)
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ClinicalTrials.gov Identifier: NCT04906395 |
Recruitment Status :
Recruiting
First Posted : May 28, 2021
Last Update Posted : May 8, 2024
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Sponsor:
Tolmar Inc.
Information provided by (Responsible Party):
Tolmar Inc.
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 12, 2021 | ||||||||
First Posted Date ICMJE | May 28, 2021 | ||||||||
Last Update Posted Date | May 8, 2024 | ||||||||
Actual Study Start Date ICMJE | July 1, 2021 | ||||||||
Estimated Primary Completion Date | April 30, 2025 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Suppression of ovarian function [ Time Frame: 6 weeks after the first administration of TOL2506 ] LH level < 4 IU/L at Week 6
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Original Primary Outcome Measures ICMJE |
Suppression of ovarian function (E2 levels and menses status) [ Time Frame: 6 weeks after the first administration of TOL2506 ] E2 levels < 20 pg/mL at Week 6 and absence of menses after Week 5
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer | ||||||||
Official Title ICMJE | Phase 3,Single Arm,Open-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 (HR+),Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer | ||||||||
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 pg/mL (testosterone levels < 50 ng/dL 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 | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 3 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Breast Cancer | ||||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Active Comparator: TOL2506
TOL2506 in combinatination with standard endocrine therapy (Tamoxifen & Aromatase Inhibitors)
Interventions:
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
250 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | April 30, 2025 | ||||||||
Estimated Primary Completion Date | April 30, 2025 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria: Female
Exclusion Criteria:
See contact information to obtain inclusion/exclusion criteria for males |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 49 Years (Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Argentina, Brazil, Canada, Mexico, Puerto Rico, United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04906395 | ||||||||
Other Study ID Numbers ICMJE | TOL2506A | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Tolmar Inc. | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Tolmar Inc. | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Tolmar Inc. | ||||||||
Verification Date | July 2023 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |