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

NCT05645536 | Enrolling By Invitation Phase 3 FDA Drug

• 1 other identifier: TOL2506A-EXT
• Study Type: interventional
• Target: 250
• Locations: 6 countries
• Sites: 47

Brief 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

Breast Cancer

Keywords

Ovarian Suppression; HR+; HER2-; Oncology; Premenopausal

Outcome Measures

Primary Outcomes (1)

• The occurrences of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

  4 years from enrolling in study

Study Arms (1)

TOL2506

EXPERIMENTAL

TOL2506 in combination with standard endocrine therapy (Tamoxifen \& Aromatase Inhibitors)

Drug: TOL2506; Drug: Tamoxifen; Drug: Letrozole tablets; Drug: Anastrozole Tablets; Drug: Exemestane Tablets

Interventions

TOL2506 DRUG

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

TOL2506

Tamoxifen DRUG

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

TOL2506

Letrozole tablets DRUG

One 2.5 mg tablet taken orally once daily

TOL2506

Anastrozole Tablets DRUG

One 1 mg tablet taken orally once daily

TOL2506

Exemestane Tablets DRUG

One 25 mg tablet taken orally once daily

TOL2506

Eligibility Criteria

• Age: 18 Years - 51 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females:
• Completed Visit 9, Week 48 visit of TOL2506A study and is a candidate for continued endocrine therapy + ovarian suppression
• Able to understand the investigational nature of this study and provide written informed consent prior to the participation in the trial
• Age 18 to 51 inclusive

You may not qualify if:

• Females:
• Body mass index (BMI) \< 18.00 kg/m2
• Life expectancy \< 12 months
• ECOG performance status ≥ 3
• Unacceptable hepatic function as determined by any of the following:
• Alanine aminotransferase (ALT) ≥ 2X upper limit of normal (ULN)
• Aspartate aminotransferase (AST) ≥ 2X ULN
• Bilirubin ≥ 2X ULN
• Alkaline phosphatase ≥ 2X ULN
• Severe hepatic impairment (Child-Pugh Class C)
• Unacceptable renal function as determined by any of the following:
• Creatinine ≥ 3X ULN
• Creatinine clearance ≤ 30 mL/minute
• Creatinine clearance ≤ 60 mL/minute in subjects with bone density 1.5 standard deviations below the young adult normal mean
• Screening 12-lead ECG demonstrating any of the following:

Sponsors & Collaborators

• Tolmar Inc.: lead

Study Sites (47)

Marin Cancer Care, Inc.

Greenbrae, California, 94904, United States

Location

Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Baptist Health Louisville

Louisville, Kentucky, 40207, United States

Location

Maryland Oncology Hematology, P.A.

Columbia, Maryland, 21044, United States

Location

Hematology Oncology Associates of Central New York, PC

East Syracuse, New York, 13057, United States

Location

Cape Fear Valley Health Systems - Cancer Center

Fayetteville, North Carolina, 28304, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

Tennessee Oncology, PLLC

Chattanooga, Tennessee, 37404, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Texas Oncology - Central South

Austin, Texas, 78745, United States

Location

Texas Oncology - Presbyterian Cancer Center

Dallas, Texas, 75231, United States

Location

Texas Oncology - Northeast Texas

Longview, Texas, 75601, United States

Location

Joe Arrington Cancer Research and Treatment Center at Covenant Children's Hospital

Lubbock, Texas, 79410, United States

Location

Texas Oncology - San Antonio

New Braunfels, Texas, 78130, United States

Location

Texas Oncology - DFW

Plano, Texas, 75075, United States

Location

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

Location

Instituto Medico de la Fundacion Estudios Clinicos

Rosario, Santa Fe Province, S2000DEJ, Argentina

Location

Hospital Aleman

Caba, C1118AAT, Argentina

Location

Fundacion CENIT

CABA, C1125ABD, Argentina

Location

Instituto Oncologico de Cordoba (IONC)

Córdoba, 5000, Argentina

Location

Centro Privado de MRI de Rio Cuarto SA

Córdoba, X5800, Argentina

Location

Sanatorio Allende

Córdoba, Argentina

Location

Centro Regional Integrado de Oncologia

Fortaleza, Ceará, 60335-480, Brazil

Location

Hospital Araujo Jorge

Goiânia, Goiás, 74605-070, Brazil

Location

Hospital do Cancer de Londrina

Londrina, Paraná, 86015, Brazil

Location

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

Uniao Brasileira de Educacao e Assistencia

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Hospital de Amor Amazonia

Porto Velho, Rondônia, 76834-899, Brazil

Location

Instituto de Educacao, Pesquisa e Gestao em Saude

Rio de Janeiro, 22775-001, Brazil

Location

Centro de Estudos e Pesquisa de Hematologia e Oncologia

Santo André, Brazil

Location

Fundacao Pio XII - Hospital de Amor Barretos

São Paulo, 14784-070, Brazil

Location

Unique Hospital Multispecialty & Research Institute

Surat, Gujarat, 395002, India

Location

SRV AGADI Hospital and Research Centre

Bangalore, Karnataka, 560027, India

Location

Oncoville Cancer Hospital and Research Centre

Bengaluru, Karnataka, 560072, India

Location

Mysore Medical College and Research Institute

Mysore, Karnataka, 570001, India

Location

KIMS - Kingsway Hospitals

Nagpur, Maharashtra, 440001, India

Location

HCG Manavata Cancer Centre

Nashik, Maharashtra, 422002, India

Location

Indrayani Hospital and Cancer Institute

Pune, Maharashtra, 412105, India

Location

Erode Cancer Centre Private Ltd.

Erode, Tamil Nadu, 638012, India

Location

Swami Harshankaranand Ji Hospital & Research Centre

Varanasi, Uttar Pradesh, 221005, India

Location

Unidad de Medicina Especializada SMA

San Juan del Río, Querétaro, 76800, Mexico

Location

CIMET Scientific Corporation S. A. P. I. de C. V.

Guadalajara, 44340, Mexico

Location

Amiisto Atencion Medica Integral, Investigacion Y Terapia Oncologica S. A. DE C. V.

Madero, Mexico

Location

Atencion Medica Integral E Investigacion en Terapia Oncologica

Mexico City, 07300, Mexico

Location

Faicic S de Rl de C. V.

Veracruz, 91900, Mexico

Location

FDI Clinical Research

San Juan, 00927, Puerto Rico

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

Tamoxifen; Letrozole; Anastrozole; exemestane

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 9, 2022
• Study Start: December 28, 2022
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: January 12, 2026

Record last verified: 2025-04

Locations

PR (1); US (17); BR (9); AR (6); ME (5); IN (9)