Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer
NCT04906395 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Tamoxifen
- DRUG TOL2506
- DRUG Letrozole Tablets
- DRUG Anastrozole Tablets
- DRUG Exemestane Tablets
Study Locations (20)
Texas
- Texas Oncology-Austin — Austin
- Texas Oncology- Dallas Presbyterian Hospital — Dallas
- Texas Oncology- San Antonio — New Braunfels
- Texas Oncology- Northeast Texas — Tyler
- Texas Oncology- Deke Slayton Cancer Center — Webster
Tennessee
- Tennessee Oncology, PLLC — Chattanooga
- Tennessee Oncology, PLLC — Nashville
Córdoba Province
- Instituto Oncologico de Cordoba (IONC) — Córdoba
- Centro Privado de RMI Rio Cuarto — Río Cuarto
California
- Marin Cancer Care, Inc — Greenbrae
Colorado
- Cypress Hematology and Oncology — Parker
Illinois
- Mount Sinai Hospital — Chicago
Kentucky
- Baptist Health Louisville — Louisville
Maryland
- Maryland Oncology Hematology, P.A. — Glenn Dale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2021-07-01 |
| Est. Completion | 2026-04-30 |
| Phase | Phase 3 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04906395
The ClinicalTrials.gov registry entry for NCT04906395 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tolmar, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions — of which Tamoxifen is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04906395 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Texas, Tennessee, Córdoba Province. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04906395 about?
NCT04906395 is a clinical study titled "Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer". 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 Perio...
What is the current status of trial NCT04906395?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 250 participants. The study started on 2021-07-01. Estimated completion is 2026-04-30.
What conditions does trial NCT04906395 study?
This clinical trial studies the following conditions: Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04906395?
The interventions under investigation include: Tamoxifen (DRUG), TOL2506 (DRUG), Letrozole Tablets (DRUG), Anastrozole Tablets (DRUG), Exemestane Tablets (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04906395?
This trial is sponsored by Tolmar, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04906395 being conducted?
This trial has 20 study locations across California, Colorado, Illinois, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.