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

January 9, 2026 updated by: Tolmar Inc.

Open-label, Safety Extension Study for Subjects With HR+, HER2-Negative Breast Cancer Who Have Completed the OVarian Suppression Evaluating Subcutaneous LeuprolIde Acetate in Breast Cancer OVELIA Study

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • CABA, Argentina, C1125ABD
        • Fundacion Cenit
      • Caba, Argentina, C1118AAT
        • Hospital Alemán
      • Córdoba, Argentina
        • Sanatorio Allende
      • Córdoba, Argentina, X5800
        • Centro Privado de MRI de Rio Cuarto SA
      • Córdoba, Argentina, 5000
        • Instituto Oncologico de Cordoba (IONC)
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000DEJ
        • Instituto Médico de la Fundación Estudios Clínicos
  • Brazil
      • Rio de Janeiro, Brazil, 22775-001
        • Instituto de Educação, Pesquisa e Gestão em Saúde
      • Santo André, Brazil
        • Centro de Estudos e Pesquisa de Hematologia e Oncologia
      • São Paulo, Brazil, 14784-070
        • Fundação PIO XII - Hospital de Amor Barretos
    • Ceará
      • Fortaleza, Ceará, Brazil, 60335-480
        • Centro Regional Integrado de Oncologia
    • Goiás
      • Goiânia, Goiás, Brazil, 74605-070
        • Hospital Araujo Jorge
    • Paraná
      • Londrina, Paraná, Brazil, 86015
        • Hospital do Câncer de Londrina
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
        • Irmandade Santa Casa de Misericordia de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • União Brasileira de Educação e Assistência
    • Rondônia
      • Porto Velho, Rondônia, Brazil, 76834-899
        • Hospital de Amor Amazônia
  • India
    • Gujarat
      • Surat, Gujarat, India, 395002
        • Unique Hospital Multispecialty & Research Institute
    • Karnataka
      • Bangalore, Karnataka, India, 560027
        • SRV AGADI Hospital and Research Centre
      • Bengaluru, Karnataka, India, 560072
        • Oncoville Cancer Hospital and Research Centre
      • Mysore, Karnataka, India, 570001
        • Mysore Medical College and Research Institute
    • Maharashtra
      • Nagpur, Maharashtra, India, 440001
        • KIMS - Kingsway Hospitals
      • Nashik, Maharashtra, India, 422002
        • HCG Manavata Cancer Centre
      • Pune, Maharashtra, India, 412105
        • Indrayani Hospital and Cancer Institute
    • Tamil Nadu
      • Erode, Tamil Nadu, India, 638012
        • Erode Cancer Centre Private Ltd.
    • Uttar Pradesh
      • Varanasi, Uttar Pradesh, India, 221005
        • Swami Harshankaranand Ji Hospital & Research Centre
  • Mexico
      • Guadalajara, Mexico, 44340
        • CIMET Scientific Corporation S. A. P. I. de C. V.
      • Madero, Mexico
        • Amiisto Atencion Medica Integral, Investigacion Y Terapia Oncologica S. A. DE C. V.
      • Mexico City, Mexico, 07300
        • Atencion Medica Integral E Investigacion en Terapia Oncologica
      • Veracruz, Mexico, 91900
        • Faicic S de Rl de C. V.
    • Querétaro
      • San Juan del Río, Querétaro, Mexico, 76800
        • Unidad de Medicina Especializada SMA
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • FDI Clinical Research
  • United States
    • California
      • Greenbrae, California, United States, 94904
        • Marin Cancer Care, Inc.
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Hospital
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
      • Louisville, Kentucky, United States, 40207
        • Baptist Health Louisville
    • Maryland
      • Columbia, Maryland, United States, 21044
        • Maryland Oncology Hematology, P.A.
    • New York
      • East Syracuse, New York, United States, 13057
        • Hematology Oncology Associates of Central New York, PC
    • North Carolina
      • Fayetteville, North Carolina, United States, 28304
        • Cape Fear Valley Health Systems - Cancer Center
    • Pennsylvania
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Medical Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology
    • Texas
      • Austin, Texas, United States, 78745
        • Texas Oncology - Central South
      • Dallas, Texas, United States, 75231
        • Texas Oncology - Presbyterian Cancer Center
      • Longview, Texas, United States, 75601
        • Texas Oncology - Northeast Texas
      • Lubbock, Texas, United States, 79410
        • Joe Arrington Cancer Research and Treatment Center at Covenant Children's Hospital
      • New Braunfels, Texas, United States, 78130
        • Texas Oncology - San Antonio
      • Plano, Texas, United States, 75075
        • Texas Oncology - DFW
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Females:

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

Exclusion Criteria:

  • Females:

    1. Body mass index (BMI) < 18.00 kg/m2
    2. Life expectancy < 12 months
    3. ECOG performance status ≥ 3

    4. Unacceptable hepatic function as determined by any of the following:

      1. Alanine aminotransferase (ALT) ≥ 2X upper limit of normal (ULN)
      2. Aspartate aminotransferase (AST) ≥ 2X ULN
      3. Bilirubin ≥ 2X ULN
      4. Alkaline phosphatase ≥ 2X ULN
      5. Severe hepatic impairment (Child-Pugh Class C)

    5. Unacceptable renal function as determined by any of the following:

      1. Creatinine ≥ 3X ULN
      2. Creatinine clearance ≤ 30 mL/minute
      3. Creatinine clearance ≤ 60 mL/minute in subjects with bone density 1.5 standard deviations below the young adult normal mean

    6. Screening 12-lead ECG demonstrating any of the following:

      1. Heart rate > 100 beats per minute (BPM)
      2. QRS > 120 msec
      3. Corrected QT (QTc) > 450 msec
      4. PR > 220 msec
    7. Use of any new medications known to prolong the QT/QTc interval
    8. 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

    9. Concomitant use of medications that may impact subject safety including but not limited to:

      1. Oral or transdermal hormonal therapy
      2. Estrogen, progesterone, or androgens
      3. Hormonal contraceptives
    10. Change in tolerability to TOL2506 that precludes continued treatment
    11. Sexually active with a male partner and not willing to use at least 2 non-hormonal contraceptive methods throughout the study
    12. Is of childbearing potential with a positive urine pregnancy test at Screening

Males:

Inclusion Criteria:

  1. Completed Visit 9, Week 48 visit of TOL2506A study and is a candidate for continued endocrine + GnRH agonist therapy
  2. Able to understand the investigational nature of this study and provide written informed consent prior to participation in the trial

Males:

Exclusion Criteria:

  1. BMI < 18.00 kg/m2
  2. Life expectancy < 12 months
  3. ECOG performance status ≥ 3

  4. Unacceptable hepatic function as determined by any of the following:

    1. ALT ≥ 2X ULN
    2. AST ≥ 2X ULN
    3. Bilirubin ≥ 2X ULN
    4. Alkaline phosphatase ≥ 2X ULN
    5. Severe hepatic impairment (Child-Pugh Class C)

  5. Unacceptable renal function as determined by any of the following:

    1. Creatinine ≥ 3X ULN
    2. Creatinine clearance ≤ 30 mL/minute
    3. Creatinine clearance ≤ 60 mL/minute in subjects with bone density 1.5 standard deviations below the young adult normal mean

  6. Screening 12-lead ECG demonstrating any of the following:

    1. HR > 100 BPM
    2. QRS > 120 msec
    3. QTc > 450 msec
    4. PR > 220 msec
  7. Use of any new medications known to prolong the QT/QTc interval
  8. 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
  9. Concomitant use of medications that may impact subject safety including but not limited to oral or transdermal hormonal therapy
  10. Change in tolerability to TOL2506 that precludes continued treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TOL2506
TOL2506 in combination with standard endocrine therapy (Tamoxifen & Aromatase Inhibitors)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The occurrences of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time Frame: 4 years from enrolling in study
4 years from enrolling in study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tolmar Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2022

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

December 1, 2022

First Submitted That Met QC Criteria

December 1, 2022

First Posted (Actual)

December 9, 2022

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOL2506A-EXT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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