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Trials
Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer

trialsTrialActive

Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer

A phase 3 trial of Tamoxifen and Exemestane in advanced solid tumours, run by Tolmar Inc., active and no longer recruiting.

Also called: OVELIA

Overview Connected5

Overview

Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer is a phase 3 interventional study registered as NCT04906395 by Tolmar Inc., with 250 participants enrolled, started 2021-07-01 and due to reach its primary completion in 2026-04-30. Interventions recorded: TOL2506, Tamoxifen, Letrozole Tablets, Anastrozole Tablets and Exemestane Tablets.

Setting

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

Phase

Phase 3

Sponsor

Tolmar Inc.

Registry

Started

2021-07-01

Enrolled

250 enrolled

Connected

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cancers

Metastatic cancer (cancer that has spread)

drugs

ApprovedSmall-molecule steroidal aromatase inactivator

Exemestane · Aromasin

ApprovedGnRH agonist depot

Leuprolide (leuprorelin) and GnRH agonists · Lupron / Eligard / Camcevi

ApprovedSmall-molecule SERM

Tamoxifen · Nolvadex

companies

Evidence strength47/100 · Emerging

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 3+30
250 enrolled+12
No structured primary endpoint0
Result: active0
No independent replication recorded0
A linked product is approved+5

Formula disclosed on the evidence page.

ProvenanceLast edited 2026-09-22 · Jude Gomila · Wave 2 corpus-only joins applied · diff · file

Sources & links

ClinicalTrials.gov NCT04906395

Data

JSON ·

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Cancers

Metastatic cancer (cancer that has spread)

Products

Tamoxifen
Exemestane
Leuprolide (leuprorelin) and GnRH agonists

Companies

Tolmar

Not yet reviewedNeeds expert (clinical) review. Review this page or see the review queue and roster.

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