Breast CancerPhase 3NCT05645536
Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study
A Phase 3 study testing TOL2506, Tamoxifen and Letrozole tablets in people with Breast Cancer, run by Tolmar Inc. at 46 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 51 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- TOL2506, Tamoxifen and Letrozole tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 46 sitesin 6 countries
- Study dates
- 28 Dec 2022to Mar 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 51 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
- Completed Visit 9, Week 48 visit of TOL2506A study and is a candidate for continued endocrine + GnRH agonist therapy
- Able to understand the investigational nature of this study and provide written informed consent prior to participation in the trial
- Males:
Who cannot join
- 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)
Show all 51Show fewer
- 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
- Change in tolerability to TOL2506 that precludes continued treatment
- Sexually active with a male partner and not willing to use at least 2 non-hormonal contraceptive methods throughout the study
- Is of childbearing potential with a positive urine pregnancy test at Screening
- Males:
- BMI < 18.00 kg/m2
- Life expectancy < 12 months
- ECOG performance status ≥ 3
- Unacceptable hepatic function as determined by any of the following:
- ALT ≥ 2X ULN
- 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:
- HR > 100 BPM
- QRS > 120 msec
- 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
- Change in tolerability to TOL2506 that precludes continued treatment.
Trial locations and contacts
46 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
46 sites in 6 countries
United States17 sites
Texas Oncology - Central South
Austin, Texas, 78745
Tennessee Oncology, PLLC
Chattanooga, Tennessee, 37404
Maryland Oncology Hematology, P.A.
Columbia, Maryland, 21044
Texas Oncology - Presbyterian Cancer Center
Dallas, Texas, 75231
Hematology Oncology Associates of Central New York, PC
East Syracuse, New York, 13057
Cape Fear Valley Health Systems - Cancer Center
Fayetteville, North Carolina, 28304
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Marin Cancer Care, Inc.
Greenbrae, California, 94904
Baptist Health Lexington
Lexington, Kentucky, 40503
Texas Oncology - Northeast Texas
Longview, Texas, 75601
Baptist Health Louisville
Louisville, Kentucky, 40207
Joe Arrington Cancer Research and Treatment Center at Covenant Children's Hospital
Lubbock, Texas, 79410
Tennessee Oncology
Nashville, Tennessee, 37203
Texas Oncology - San Antonio
New Braunfels, Texas, 78130
Texas Oncology - DFW
Plano, Texas, 75075
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
Brazil9 sites
Centro Regional Integrado de Oncologia
Fortaleza, Ceará, 60335-480
Hospital Araujo Jorge
Goiânia, Goiás, 74605-070
Hospital do Cancer de Londrina
Londrina, Paraná, 86015
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170
Uniao Brasileira de Educacao e Assistencia
Porto Alegre, Rio Grande do Sul, 90610-000
Hospital de Amor Amazonia
Porto Velho, Rondônia, 76834-899
Instituto de Educacao, Pesquisa e Gestao em Saude
Rio de Janeiro, 22775-001
Centro de Estudos e Pesquisa de Hematologia e Oncologia
Santo André
Fundacao Pio XII - Hospital de Amor Barretos
São Paulo, 14784-070
India8 sites
SRV AGADI Hospital and Research Centre
Bangalore, Karnataka, 560027
Oncoville Cancer Hospital and Research Centre
Bengaluru, Karnataka, 560072
Erode Cancer Centre Private Ltd.
Erode, Tamil Nadu, 638012
Mysore Medical College and Research Institute
Mysore, Karnataka, 570001
KIMS - Kingsway Hospitals
Nagpur, Maharashtra, 440001
Indrayani Hospital and Cancer Institute
Pune, Maharashtra, 412105
Unique Hospital Multispecialty & Research Institute
Surat, Gujarat, 395002
Swami Harshankaranand Ji Hospital & Research Centre
Varanasi, Uttar Pradesh, 221005
Argentina6 sites
Hospital Aleman
Caba, C1118AAT
Fundacion CENIT
CABA, C1125ABD
Instituto Oncologico de Cordoba (IONC)
Córdoba, 5000
Centro Privado de MRI de Rio Cuarto SA
Córdoba, X5800
Sanatorio Allende
Córdoba
Instituto Medico de la Fundacion Estudios Clinicos
Rosario, Santa Fe Province, S2000DEJ
Mexico5 sites
CIMET Scientific Corporation S. A. P. I. de C. V.
Guadalajara, 44340
Amiisto Atencion Medica Integral, Investigacion Y Terapia Oncologica S. A. DE C. V.
Madero
Atencion Medica Integral E Investigacion en Terapia Oncologica
Mexico City, 07300
Unidad de Medicina Especializada SMA
San Juan del Río, Querétaro, 76800
Faicic S de Rl de C. V.
Veracruz, 91900
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Being tested
- TOL2506, Tamoxifen, Letrozole tablets, Anastrozole Tablets, Exemestane Tablets
- Keywords
- Ovarian Suppression, HR+, HER2-, Oncology, Premenopausal
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOL2506Drug
Leuprolide Acetate for injectable suspension, 30 mg. Subcutaneous injection every 3 months
TamoxifenDrug
20 mg once daily or 10 mg 2 times daily - either tablet of solution
Letrozole tabletsDrug
One 2.5 mg tablet taken orally once daily
Anastrozole TabletsDrug
One 1 mg tablet taken orally once daily
Exemestane TabletsDrug
One 25 mg tablet taken orally once daily
| Study group | Role | What they receive |
|---|---|---|
| TOL2506 | Experimental | TOL2506 in combination with standard endocrine therapy (Tamoxifen \& Aromatase Inhibitors) Receives: Drug: TOL2506; Drug: Tamoxifen; Drug: Letrozole tablets; Drug: Anastrozole Tablets; Drug: Exemestane Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrences of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Measured: 4 years from enrolling in study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start28 Dec 2022
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tolmar Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645536
- Sponsor's protocol ID
- TOL2506A-EXT
- Status last verified
- Aug 2026
- First submitted
- 1 Dec 2022
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05645536
- Acronym / sponsor ID
- TOL2506A-EXT
- Conditions
- Breast Cancer
- Keywords
- Ovarian Suppression, HR+, HER2-, Oncology, Premenopausal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Tolmar Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Dec 2022 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TOL2506 | Experimental | Drug: TOL2506, Drug: Tamoxifen, Drug: Letrozole tablets, Drug: Anastrozole Tablets, Drug: Exemestane TabletsTOL2506 in combination with standard endocrine therapy (Tamoxifen \& Aromatase Inhibitors) |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
- Completed Visit 9, Week 48 visit of TOL2506A study and is a candidate for continued endocrine + GnRH agonist therapy
- Able to understand the investigational nature of this study and provide written informed consent prior to participation in the trial
Key exclusion criteria (51 listed)
- Females:
- BMI < 18.00 kg/m2
- Life expectancy < 12 months
- ECOG performance status ≥ 3
- Unacceptable hepatic function as determined by any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TOL2506Leuprolide Acetate for injectable suspension, 30 mg. Subcutaneous injection every 3 months | Drug | TOL2506 |
| Tamoxifen20 mg once daily or 10 mg 2 times daily - either tablet of solution | Drug | TOL2506 |
| Letrozole tabletsOne 2.5 mg tablet taken orally once daily | Drug | TOL2506 |
| Anastrozole TabletsOne 1 mg tablet taken orally once daily | Drug | TOL2506 |
| Exemestane TabletsOne 25 mg tablet taken orally once daily | Drug | TOL2506 |
Primary outcome
The occurrences of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: 4 years from enrolling in study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
46 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TOL2506, Tamoxifen and Letrozole tablets in people with Breast Cancer, run by Tolmar Inc. at 46 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 51 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, Brazil, India, Argentina, Mexico and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrences of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) (time frame: 4 years from enrolling in study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.