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

Enrolling by invitation · Phase 3

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT05645536

Run by

Tolmar Inc.

People needed

250

Starts

2022-12-28

Expected to finish

2028-06-01

Last updated by the study team

2026-01-12

Who can join

Age: 18 and older, up to 51. Sex: any. Healthy volunteers: not accepted.

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:
• Heart rate > 100 beats per minute (BPM)
• QRS > 120 msec
• Corrected QT (QTc) > 450 msec
• PR > 220 msec
• Use of any new medications known to prolong the QT/QTc interval
• Any new medical condition or psychiatric, addictive or other disorder that, in the opinion of the Investigator, may interfere with trial conduct or result in the subject being ineligible to continue treatment with TOL2506
• Concomitant use of medications that may impact subject safety including but not limited to:
• Oral or transdermal hormonal therapy
• Estrogen, progesterone, or androgens
• Hormonal contraceptives

Where it is running

• Marin Cancer Care, Inc. — Greenbrae, California, United States
• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• Baptist Health Lexington — Lexington, Kentucky, United States
• Baptist Health Louisville — Louisville, Kentucky, United States
• Maryland Oncology Hematology, P.A. — Columbia, Maryland, United States
• Hematology Oncology Associates of Central New York, PC — East Syracuse, New York, United States
• Cape Fear Valley Health Systems - Cancer Center — Fayetteville, North Carolina, United States
• Lankenau Medical Center — Wynnewood, Pennsylvania, United States
• Tennessee Oncology, PLLC — Chattanooga, Tennessee, United States
• Tennessee Oncology — Nashville, Tennessee, United States
• Texas Oncology - Central South — Austin, Texas, United States
• Texas Oncology - Presbyterian Cancer Center — Dallas, Texas, United States
• Texas Oncology - Northeast Texas — Longview, Texas, United States
• Joe Arrington Cancer Research and Treatment Center at Covenant Children's Hospital — Lubbock, Texas, United States
• Texas Oncology - San Antonio — New Braunfels, Texas, United States
• Texas Oncology - DFW — Plano, Texas, United States
• Fred Hutchinson Cancer Center — Seattle, Washington, United States
• Instituto Medico de la Fundacion Estudios Clinicos — Rosario, Santa Fe Province, Argentina
• Hospital Aleman — Caba, Argentina
• Fundacion CENIT — CABA, Argentina
• Instituto Oncologico de Cordoba (IONC) — Córdoba, Argentina
• Centro Privado de MRI de Rio Cuarto SA — Córdoba, Argentina
• Sanatorio Allende — Córdoba, Argentina
• Centro Regional Integrado de Oncologia — Fortaleza, Ceará, Brazil
• Hospital Araujo Jorge — Goiânia, Goiás, Brazil

Full record on ClinicalTrials.gov

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