Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study
Key facts
- Where
- Fortaleza, Goiânia, Londrina, Porto Alegre, Porto Velho, Rio de Janeiro, Santo André, and São Paulo, BrazilSee the 9 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 51 years old?
Source: NCT05645536, who can take part
Where in Brazil
- Centro Regional Integrado de OncologiaFortaleza, BrazilNo longer taking part
- Hospital Araújo JorgeGoiânia, BrazilNo longer taking part
- Hospital do Câncer de LondrinaLondrina, BrazilNo longer taking part
- Irmandade Santa Casa de Misericordia de Porto AlegrePorto Alegre, BrazilNo longer taking part
- Uniao Brasileira de Educacao e AssistenciaPorto Alegre, BrazilNo longer taking part
- Hospital de Amor AmazôniaPorto Velho, BrazilNo longer taking part
- Instituto de Educacao Pesquisa e Gestao em SaudeRio de Janeiro, BrazilNo longer taking part
- Centro de Estudos e Pesquisa de Hematologia e OncologiaSanto André, BrazilNo longer taking part
- Fundacao Pio XII - Hospital de Amor BarretosSão Paulo, BrazilNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tolmar Inc.
- Trial code
- NCT05645536
- Record updated
- 23 October 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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:.
Exclusion: 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; 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); 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:; 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; BMI < 18.00 kg/m2; Life expectancy < 12 months; ECOG performance status ≥ 3; Change in tolerability to TOL2506 that precludes continued treatment.