TOL2506 + Standard Therapy for Breast Cancer

Recruiting in Palo Alto (17 mi)

+21 other locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Tolmar Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for premenopausal women and men with HR+, HER2- breast cancer who completed the TOL2506A study. Women must be aged 18 to 51, and all participants should consent to continue therapy. Exclusions include severe health issues like poor heart, liver or kidney function, low BMI (<18), high ECOG status (≥3), certain medications that affect safety or response to treatment, and life expectancy less than a year.

Inclusion Criteria

I understand this study is experimental and I agree to participate.

I am a male who has finished Week 48 of the TOL2506A study and can continue hormone therapy.

I finished Week 48 of the TOL2506A study and can continue hormone therapy with ovarian suppression.

+2 more

Exclusion Criteria

I am a male taking medications that may affect my safety with TOL2506.

I am a man mostly confined to bed or chair due to my health.

My liver tests are not normal, indicating poor liver function.

+11 more

Participant Groups

The study tests the long-term safety of TOL2506 combined with tamoxifen or an aromatase inhibitor (AI) in suppressing ovarian function in women and endocrine plus GnRH agonist therapy in men for up to four years after completing the initial OVELIA study.

1Treatment groups

Experimental Treatment

Group I: TOL2506Experimental Treatment5 Interventions

TOL2506 in combination with standard endocrine therapy (Tamoxifen \& Aromatase Inhibitors)

TOL2506 is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Eligard for: