By InvitationPhase 3

Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study

United States250 participantsStarted 2022-12-28

Plain-language 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.

Who can participate

Age range18 Years – 51 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

The occurrences of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

Timeframe: 4 years from enrolling in study

Trial details

NCT IDNCT05645536

SponsorTolmar Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-06

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