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Active, not recruiting Phase 3 Interventional

Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer

ClinicalTrials.gov ID: NCT04906395

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.

ClinicalTrials.gov public records Last synced Jul 23, 2026, 1:29 PM EDT

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

Study identification

NCT ID
NCT04906395
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Tolmar Inc.
Industry
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 Jul 23, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04906395 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →