Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study
NCT ID: NCT05645536
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
PHASE3
250 participants
INTERVENTIONAL
2022-12-28
2028-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer
NCT04906395
Study of Breast Cancer Prevention by Letrozole in High Risk Women
NCT00579826
Study of XL147 (SAR245408) or XL765 (SAR245409) in Combination With Letrozole in Subjects With Breast Cancer
NCT01082068
Letrozole in Preventing Cancer in Postmenopausal Women Who Have Received 4-6 Years of Hormone Therapy for Hormone Receptor-Positive, Lymph Node-Positive, Early-Stage Breast Cancer
NCT00553410
Letrozole After Tamoxifen in Treating Women With Breast Cancer
NCT00003140
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TOL2506
TOL2506 in combination with standard endocrine therapy (Tamoxifen \& Aromatase Inhibitors)
TOL2506
Leuprolide Acetate for injectable suspension, 30 mg. Subcutaneous injection every 3 months
Tamoxifen
20 mg once daily or 10 mg 2 times daily - either tablet of solution
Letrozole tablets
One 2.5 mg tablet taken orally once daily
Anastrozole Tablets
One 1 mg tablet taken orally once daily
Exemestane Tablets
One 25 mg tablet taken orally once daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TOL2506
Leuprolide Acetate for injectable suspension, 30 mg. Subcutaneous injection every 3 months
Tamoxifen
20 mg once daily or 10 mg 2 times daily - either tablet of solution
Letrozole tablets
One 2.5 mg tablet taken orally once daily
Anastrozole Tablets
One 1 mg tablet taken orally once daily
Exemestane Tablets
One 25 mg tablet taken orally once daily
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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. 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:
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.
18 Years
51 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tolmar Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Hospital do Cancer de Londrina
Londrina, Paraná, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Uniao Brasileira de Educacao e Assistencia
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Amor Amazonia
Porto Velho, Rondônia, Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude
Rio de Janeiro, , Brazil
Centro de Estudos e Pesquisa de Hematologia e Oncologia
Santo André, , Brazil
Fundacao Pio XII - Hospital de Amor Barretos
São Paulo, , Brazil
Unique Hospital Multispecialty & Research Institute
Surat, Gujarat, India
SRV AGADI Hospital and Research Centre
Bangalore, Karnataka, India
Oncoville Cancer Hospital and Research Centre
Bengaluru, Karnataka, India
Mysore Medical College and Research Institute
Mysore, Karnataka, India
KIMS - Kingsway Hospitals
Nagpur, Maharashtra, India
HCG Manavata Cancer Centre
Nashik, Maharashtra, India
Indrayani Hospital and Cancer Institute
Pune, Maharashtra, India
Erode Cancer Centre Private Ltd.
Erode, Tamil Nadu, India
Swami Harshankaranand Ji Hospital & Research Centre
Varanasi, Uttar Pradesh, India
Unidad de Medicina Especializada SMA
San Juan del Río, Querétaro, Mexico
CIMET Scientific Corporation S. A. P. I. de C. V.
Guadalajara, , Mexico
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, , Mexico
Faicic S de Rl de C. V.
Veracruz, , Mexico
FDI Clinical Research
San Juan, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TOL2506A-EXT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.