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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
TOL2506A (OVELIA) is a Phase 3, single arm, open-label study evaluating the effectiveness of TOL2506 in suppressing ovarian function in premenopausal women with HR+, HER2-negative breast cancer and men with HR+ breast cancer. The TOL2506A-EXT study described here is a safety extension study to assess and collect long-term data on the ongoing safety and tolerability of TOL2506 in combination with tamoxifen or an AI for up to 4 years.
Study identification
- NCT ID
- NCT05645536
- Recruitment status
- Enrolling by invitation
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 250 participants
Conditions and interventions
Conditions
Interventions
- TOL2506 Drug
- Tamoxifen Drug
- Letrozole tablets Drug
- Anastrozole Tablets Drug
- Exemestane Tablets 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 28, 2022 (Actual)
- Primary completion
- Mar 2030 (Estimated)
- Completion
- Mar 2030 (Estimated)
- Last update posted
- Sep 1, 2026
2022 – 2030
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 Sep 1, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05645536 live on ClinicalTrials.gov.