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New injection aims to halt ovarian function in breast cancer fight

NCT ID NCT04906395

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This phase 3 study tests a 3-month injection (TOL2506) to temporarily stop ovarian function in premenopausal women with HR+, HER2-negative breast cancer. The goal is to see if it works well with hormone therapy (tamoxifen or aromatase inhibitors) to control the cancer. About 250 participants will receive the injection and be monitored for 48 weeks. The study also checks safety in men with the same cancer type.

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

Jul 2021

Expected to finish

Apr 2026

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 49 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: Female 1. Able to understand the investigational nature of this study and provide written informed consent prior to the participation in the trial 2. Age 18 to 49, inclusive 3. Diagnosis of Stage I, II, or III HR+, HER2-negative breast cancer (ER\>1% and/or, PR\>1%, HER2-negative per ASCO CAP guidelines) 4. Is a candidate for endocrine therapy + ovarian suppression LH \> 4 IU/L within 28 days prior to Day 1 5. Is premenopausal as defined by: * E2 \> 30 pg/mL * follicle stimulating hormone (FSH) \< 40 IU/L * regular menses (eg, menstrual cycle length of 21 to 35 days) Note: premenopausal status must be determined before neo/adjuvant chemotherapy in patients for which it is planned or prior to Day 1 in patients who did not have prior chemotherapy. If premenopausal status was not determined prior to chemotherapy, E2 and FSH must meet the above criteria when measured 2 weeks or more after the end of the final cycle of chemotherapy. Exclusion Criteria: 1. Body mass index (BMI) \< 18.00 kg/m2 or \> 35.00 kg/m2 2. Breastfeeding 3. Life expectancy \< 12 months 4. Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3 5. 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) 6. 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 7. History of significantly abnormal ECG or 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 8. Prior (within 28 days prior to Day 1) and/or concomitant use of medications known to prolong the QT/QTc interval 9. Prior use of tamoxifen, other SERMs (eg, raloxifene) or antagonists (eg, fulvestrant), aromatase inhibitor, mammalian target of rapamycin (mTOR) inhibitors, or hormone replacement therapy within 3 months before breast cancer diagnosis 10. Concomitant use of anticancer mediations other than those specified for use by the protocol 11. Prior neoadjuvant or adjuvant endocrine therapy since diagnosis of breast cancer 12. History of treatment for osteopenia/osteoporosis or baseline bone mineral density Z-score ≤ -2.0 13. Prior (within 6 months prior to Day 1) or current use of drugs known to increase bone mineral density (ie, bisphosphonates, denosumab, teriparatide, abaloparatide, romosozumab) or use of supplements known to increase bone mineral density (ie, calcitonin, fluoride, strontium) within 28 days prior to Day 1 14. Low trauma fracture(s) occurring within 12 months prior to subject's first visit (defined as a fracture that results from a fall from a standing height or less, excluding fingers, toes, face and skull) 15. Conditions that preclude bone mineral density measurement (lumbar spine/bilateral hip surgery with hardware in place, abdominal clips, umbilical ring \[not willing to remove\] or weight that exceeds the DEXA machine limitation) 16. Any other medical condition or serious illness, presence of a second malignancy under current treatment or follow-up, or the presence of clinically significant findings on the physical exam, laboratory testing, medical history (including conditions that may be associated with low bone mass), that in the opinion of the Investigator may interfere with trial conduct, subject safety, or interpretation of study results 17. Already receiving and/or previously received GnRH analogs within 1 year before breast cancer diagnosis 18. Psychiatric, addictive, or other disorders that would preclude study compliance 19. Use of medications that may impact subject safety and/or affect the PK of the drug and hormonal assessments including but not limited to: 1. Oral or transdermal hormonal therapy within 30 days prior to subject's first visit 2. Estrogen, progesterone, or androgens within 30 days prior to subject's first visit 3. Hormonal contraceptives within 30 days prior to subject's first visit 4. Medications known to result in clinically important decreases in bone mass taken within 6 months prior to subject's first visit 20. Known hypersensitivity, idiosyncratic, or allergic reactions to GnRH, GnRH agonist/analogs or to any of the components of the IP 21. Sexually active with a male partner and not willing to use non-hormonal contraceptive methods throughout the study 22. Is of childbearing potential with a positive serum pregnancy test at Screening or urine pregnancy test at Day 1 23. Exposure to any investigational agent within 30 days prior to the first dose of TOL2506 See contact information to obtain inclusion/exclusion criteria for males

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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

Contacts and locations

Locations

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

    Mexico City, Mexico City, 07300, Mexico

  • Apollo Cancer Hospitals

    Hyderabad, Telangana, 500096, India

  • Apollo Hospitals

    Visakhapatnam, Andhra Pradesh, 530040, India

  • Baptist Health Louisville

    Louisville, Kentucky, 40207, United States

  • Centro Privado de RMI Rio Cuarto

    Río Cuarto, Córdoba Province, 5800, Argentina

  • Centro Regional Integrado de Oncologia

    Fortaleza, Ceará, 60335-480, Brazil

  • Centro de Estudos e Pesquisas de Hematologia e Oncologia da Faculdade de Medicina do ABC

    Santo André, São Paulo, 09060-650, Brazil

  • Clinica EMA

    Mexico City, 03339, Mexico

  • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria

    São Paulo, São Paulo, 01317-001, Brazil

  • Cypress Hematology and Oncology

    Parker, Colorado, 80138, United States

  • Erode Cancer Centre Private Ltd.

    Erode, Tamil Nadu, 638012, India

  • FAICIC S. de R.L. de C.V.

    Veracruz, 91900, Mexico

  • FDI Clinical Research

    San Juan, 00927, Puerto Rico

  • Fundacao Pio XII

    Barretos, São Paulo, 14784-400, Brazil

  • Fundacion CENIT

    CABA, C1125ABD, Argentina

  • HCG Cancer Centre

    Visakhapatnam, Andhra Pradesh, 530040, India

  • HCG City Cancer Centre

    Vijayawada, Andhra Pradesh, 520002, India

  • HCG Manavata Cancer Centre

    Nashik, Maharashtra, 42202, India

  • Hemato Oncology Clinic Ahmedabad Pvt. Ltd.

    Ahmedabad, Gujarat, 380054, India

  • Hospital Aleman

    Buenos Aires, C118AAT, Argentina

  • Hospital Araujo Jorge

    Goiânia, Goiás, 74605-070, Brazil

  • Hospital Britanico de Buenos Aires

    Buenos Aires, Buenos Aires F.D., C1480AEB, Argentina

  • Hospital Provincial del Centenario

    Rosario, Santa Fe Province, S2000KDS, Argentina

  • Hospital Sao Rafael

    Salvador, Estado de Bahia, 41253-190, Brazil

  • Hospital de Amor Amazonia

    Porto Velho, Rondônia, 76834-899, Brazil

  • Hospital do Cancer de Londrina

    Londrina, Paraná, 86015-520, 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, Córdoba Province, 5000, Argentina

  • Instituto de Educacao, Pesquisa e Gestao em Saude

    Rio de Janeiro, 22775-001, Brazil

  • Irmamandade de Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90020-090, Brazil

  • KIMS-Kingsway Hospitals, SPANV Medisearch Lifesciences

    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.

    Glenn Dale, Maryland, 20769, United States

  • Montefiore - Einstein Center for Cancer Care at Montefiore Medical Park

    The Bronx, New York, 10461, United States

  • Mount Sinai Hospital

    Chicago, Illinois, 60608, United States

  • Mysore Medical College and Research Institute

    Mysore, Karnataka, 570001, India

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68114, United States

  • Oncocentro Servicos Medicos e Hospitalares Ltda

    Fortaleza, Ceará, 60135-237, Brazil

  • Oncology Hematology Care Clinical Trials

    Cincinnati, Ohio, 45211, United States

  • Onconeo

    Campo Grande, Mato Grosso do Sul, 79002-061, Brazil

  • Oncoville Cancer Hospital and Research Center

    Bengaluru, Karnataka, 560072, India

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 1Z5, Canada

  • SRV AGADI Hospital and Research Centre

    Bengaluru, Karnataka, 560027, India

  • Sanatorio Allende- Sede Nueva Cordoba

    Córdoba, X5000JHQ, Argentina

  • Seattle Cancer Center Alliance

    Seattle, Washington, 98109, United States

  • Sunnybrook Odette Cancer Centre Clinical Research Program

    Toronto, Ontario, M4N 3M5, Canada

  • Swami Harshankaranand Ji Hospital & Research Centre

    Varanasi, Uttar Pradesh, 221004, India

  • Tennessee Oncology, PLLC

    Chattanooga, Tennessee, 37404, United States

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203, United States

  • Texas Oncology- Dallas Presbyterian Hospital

    Dallas, Texas, 75231, United States

  • Texas Oncology- Deke Slayton Cancer Center

    Webster, Texas, 77598, United States

  • Texas Oncology- Northeast Texas

    Tyler, Texas, 75702, United States

  • Texas Oncology- San Antonio

    New Braunfels, Texas, 78130, United States

  • Texas Oncology-Austin

    Austin, Texas, 78731, 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.