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Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study

NCT05645536 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-01-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

TOL2506

Leuprolide Acetate for injectable suspension, 30 mg. Subcutaneous injection every 3 months

DRUG

Tamoxifen

20 mg once daily or 10 mg 2 times daily - either tablet of solution

DRUG

Letrozole tablets

One 2.5 mg tablet taken orally once daily

DRUG

Anastrozole Tablets

One 1 mg tablet taken orally once daily

DRUG

Exemestane Tablets

One 25 mg tablet taken orally once daily

Sponsors & Collaborators

  • Tolmar Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
51 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-28
Primary Completion
2028-06-30
Completion
2028-06-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • India
  • Mexico
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05645536 on ClinicalTrials.gov