Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer
Public ClinicalTrials.gov record NCT04906395. 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
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
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04906395
- Recruitment status
- Active, not recruiting
- 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 49 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
- Jun 30, 2021
- Primary completion
- Apr 29, 2026
- Completion
- Apr 29, 2026
- Last update posted
- Jan 12, 2026
2021 – 2026
United States locations
- U.S. sites
- 17
- U.S. states
- 12
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Marin Cancer Care, Inc | Greenbrae | California | 94904 | — |
| Cypress Hematology and Oncology | Parker | Colorado | 80138 | — |
| Mount Sinai Hospital | Chicago | Illinois | 60608 | — |
| Baptist Health Louisville | Louisville | Kentucky | 40207 | — |
| Maryland Oncology Hematology, P.A. | Glenn Dale | Maryland | 20769 | — |
| Nebraska Cancer Specialists | Omaha | Nebraska | 68114 | — |
| Montefiore - Einstein Center for Cancer Care at Montefiore Medical Park | The Bronx | New York | 10461 | — |
| Oncology Hematology Care Clinical Trials | Cincinnati | Ohio | 45211 | — |
| Lankenau Medical Center | Wynnewood | Pennsylvania | 19096 | — |
| Tennessee Oncology, PLLC | Chattanooga | Tennessee | 37404 | — |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37203 | — |
| Texas Oncology-Austin | Austin | Texas | 78731 | — |
| Texas Oncology- Dallas Presbyterian Hospital | Dallas | Texas | 75231 | — |
| Texas Oncology- San Antonio | New Braunfels | Texas | 78130 | — |
| Texas Oncology- Northeast Texas | Tyler | Texas | 75702 | — |
| Texas Oncology- Deke Slayton Cancer Center | Webster | Texas | 77598 | — |
| Seattle Cancer Center Alliance | 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 42 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04906395, 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 12, 2026 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04906395 live on ClinicalTrials.gov.