Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study
Public ClinicalTrials.gov record NCT05645536. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Open-label, Safety Extension Study for Subjects With HR+, HER2-Negative Breast Cancer Who Have Completed the OVarian Suppression Evaluating Subcutaneous LeuprolIde Acetate in Breast Cancer OVELIA Study
Study identification
- NCT ID
- NCT05645536
- Recruitment status
- Enrolling by invitation
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Tolmar Inc.
- Industry
- Enrollment
- 250 participants
Conditions and interventions
Conditions
Interventions
- Anastrozole Tablets Drug
- Exemestane Tablets Drug
- Letrozole tablets Drug
- TOL2506 Drug
- Tamoxifen Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 51 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 27, 2022
- Primary completion
- May 31, 2028
- Completion
- May 31, 2028
- Last update posted
- Jan 11, 2026
2022 – 2028
United States locations
- U.S. sites
- 17
- U.S. states
- 10
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Marin Cancer Care, Inc. | Greenbrae | California | 94904 | — |
| Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | — |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | — |
| Baptist Health Louisville | Louisville | Kentucky | 40207 | — |
| Maryland Oncology Hematology, P.A. | Columbia | Maryland | 21044 | — |
| Hematology Oncology Associates of Central New York, PC | East Syracuse | New York | 13057 | — |
| Cape Fear Valley Health Systems - Cancer Center | Fayetteville | North Carolina | 28304 | — |
| Lankenau Medical Center | Wynnewood | Pennsylvania | 19096 | — |
| Tennessee Oncology, PLLC | Chattanooga | Tennessee | 37404 | — |
| Tennessee Oncology | Nashville | Tennessee | 37203 | — |
| Texas Oncology - Central South | Austin | Texas | 78745 | — |
| Texas Oncology - Presbyterian Cancer Center | Dallas | Texas | 75231 | — |
| Texas Oncology - Northeast Texas | Longview | Texas | 75601 | — |
| Joe Arrington Cancer Research and Treatment Center at Covenant Children's Hospital | Lubbock | Texas | 79410 | — |
| Texas Oncology - San Antonio | New Braunfels | Texas | 78130 | — |
| Texas Oncology - DFW | Plano | Texas | 75075 | — |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 30 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05645536, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 11, 2026 · Synced May 14, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05645536 live on ClinicalTrials.gov.