Breast Cancer
Conditions
Keywords
Ovarian Suppression, HR+, HER2-, Oncology, Premenopausal
Brief 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. 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.
Interventions
DRUGTOL2506
Leuprolide Acetate for injectable suspension, 30 mg. Subcutaneous injection every 3 months
DRUGTamoxifen
20 mg once daily or 10 mg 2 times daily - either tablet of solution
One 2.5 mg tablet taken orally once daily
One 1 mg tablet taken orally once daily
One 25 mg tablet taken orally once daily
Sponsors
Tolmar Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 51 Years
Healthy volunteers
No
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:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrences of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) | 4 years from enrolling in study |
Countries
Argentina, Brazil, India, Mexico, Puerto Rico, United States
Outcome results
None listed