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Breast cancer patients monitored for years in new safety trial

NCT ID NCT05645536

Disease control Sponsor: Tolmar Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times

Summary

This study looks at the long-term safety of a drug called TOL2506, which suppresses ovarian function, in people with hormone receptor-positive (HR+) breast cancer. It includes premenopausal women and men who already completed a previous study. Participants will take TOL2506 along with tamoxifen or an aromatase inhibitor for up to 4 years, and researchers will track any side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 51 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    47 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    Madero, Mexico

  • Atencion Medica Integral E Investigacion en Terapia Oncologica

    Mexico City, 07300, Mexico

  • Baptist Health Lexington

    Lexington, Kentucky, 40503, United States

  • Baptist Health Louisville

    Louisville, Kentucky, 40207, United States

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

    Guadalajara, 44340, Mexico

  • Cape Fear Valley Health Systems - Cancer Center

    Fayetteville, North Carolina, 28304, United States

  • Centro Privado de MRI de Rio Cuarto SA

    Córdoba, X5800, Argentina

  • Centro Regional Integrado de Oncologia

    Fortaleza, Ceará, 60335-480, Brazil

  • Centro de Estudos e Pesquisa de Hematologia e Oncologia

    Santo André, Brazil

  • Erode Cancer Centre Private Ltd.

    Erode, Tamil Nadu, 638012, India

  • FDI Clinical Research

    San Juan, 00927, Puerto Rico

  • Faicic S de Rl de C. V.

    Veracruz, 91900, Mexico

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • Fundacao Pio XII - Hospital de Amor Barretos

    São Paulo, 14784-070, Brazil

  • Fundacion CENIT

    CABA, C1125ABD, Argentina

  • HCG Manavata Cancer Centre

    Nashik, Maharashtra, 422002, India

  • Hematology Oncology Associates of Central New York, PC

    East Syracuse, New York, 13057, United States

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308, United States

  • Hospital Aleman

    Caba, C1118AAT, Argentina

  • Hospital Araujo Jorge

    Goiânia, Goiás, 74605-070, Brazil

  • Hospital de Amor Amazonia

    Porto Velho, Rondônia, 76834-899, Brazil

  • Hospital do Cancer de Londrina

    Londrina, Paraná, 86015, Brazil

  • Indrayani Hospital and Cancer Institute

    Pune, Maharashtra, 412105, India

  • Instituto Medico de la Fundacion Estudios Clinicos

    Rosario, Santa Fe Province, S2000DEJ, Argentina

  • Instituto Oncologico de Cordoba (IONC)

    Córdoba, 5000, Argentina

  • Instituto de Educacao, Pesquisa e Gestao em Saude

    Rio de Janeiro, 22775-001, Brazil

  • Irmandade Santa Casa de Misericordia de Porto Alegre

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

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

    Lubbock, Texas, 79410, United States

  • KIMS - Kingsway Hospitals

    Nagpur, Maharashtra, 440001, India

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096, United States

  • Marin Cancer Care, Inc.

    Greenbrae, California, 94904, United States

  • Maryland Oncology Hematology, P.A.

    Columbia, Maryland, 21044, United States

  • Mysore Medical College and Research Institute

    Mysore, Karnataka, 570001, India

  • Oncoville Cancer Hospital and Research Centre

    Bengaluru, Karnataka, 560072, India

  • SRV AGADI Hospital and Research Centre

    Bangalore, Karnataka, 560027, India

  • Sanatorio Allende

    Córdoba, Argentina

  • Swami Harshankaranand Ji Hospital & Research Centre

    Varanasi, Uttar Pradesh, 221005, India

  • Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • Tennessee Oncology, PLLC

    Chattanooga, Tennessee, 37404, United States

  • Texas Oncology - Central South

    Austin, Texas, 78745, United States

  • Texas Oncology - DFW

    Plano, Texas, 75075, United States

  • Texas Oncology - Northeast Texas

    Longview, Texas, 75601, United States

  • Texas Oncology - Presbyterian Cancer Center

    Dallas, Texas, 75231, United States

  • Texas Oncology - San Antonio

    New Braunfels, Texas, 78130, United States

  • Uniao Brasileira de Educacao e Assistencia

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

  • Unidad de Medicina Especializada SMA

    San Juan del Río, Querétaro, 76800, Mexico

  • Unique Hospital Multispecialty & Research Institute

    Surat, Gujarat, 395002, India

More trials for these conditions

Other studies related to the condition(s) this trial covers.