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Tamoxifen

Exemestane

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Estrogen Receptor Modulators

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

Leuprolide Acetate for injectable suspension, 30 mg. Subcutaneous injection every 3 months

TOL2506

20 mg once daily or 10 mg 2 times daily - either tablet of solution

One 2.5 mg tablet taken orally once daily

Letrozole tablets

Anastrozole Tablets

Exemestane Tablets

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.

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

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

Tolmar Inc.

Mitogens

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

Leuprolide Acetate for injectable suspension, 30 mg. Subcutaneous injection every 3 months.

20 mg once daily or 10 mg 2 times daily - either tablet or solution

Letrozole Tablets

A Mehta

C Fajardo

E P Hamilton

This is a phase 3, single arm, open-label study evaluating the effectiveness of TOL2506 to suppress ovarian function in premenopausal women with HR+, HER2-negative breast cancer. The study will also aim to assess the safety of TOL2506 in men with HR+, HER2-negative breast cancer. The Screening Period will be conducted in two parts: 1) an abbreviated, initial screening where premenopausal status will be determined prior to neoadjuvant or adjuvant chemotherapy (if planned) and 2) the full screening assessment conducted after neoadjuvant or adjuvant chemotherapy (or for subjects who enter the study without having received chemotherapy). Following the Screening Period, eligible subjects will enter into the 48 week Treatment Period in 1 of 2 groups: those who will receive tamoxifen concurrently with TOL2506 or those who will initiate therapy with an AI (letrozole, anastrozole, or exemestane) beginning 6 weeks after the first administration of TOL2506, upon confirmation that estradiol (E2) levels of \< 20 pg/mL (testosterone levels \< 50 ng/dL in males) have been achieved. After Week 12, subjects will be allowed to switch from receiving an AI to receiving tamoxifen or from tamoxifen to AI at the discretion of the Investigator. However, a switch is not permitted 28 days prior to a dosing visit (eg, Week 24, 36, and 48 where a pre-dose blood sample for PK and PD analysis will be drawn). At the end of the Treatment Period, upon completion of the End of Study Visit (Visit 9, Week 48) subjects may be eligible to participate in a Safety Extension Study under a separate Protocol.

Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer

Phase 3,Single Arm,Open-Label Study Evaluating Ovarian Suppression Following 3 Month Leuprolide Acetate For Injectable Suspension (TOL2506) in Combination With Endocrine Therapy in Premenopausal Subjects With Hormone-Receptor-Positive (HR+),Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

Percent of all subjects with LH \< 4 IU/L, E2 \<20 pg/mL in subjects treated with TOL2506 + endocrine therapy (tamoxifen or aromatase inhibitors) at every measurement from Week 6 to Week 48

Percent of all subjects with LH \< 4 IU/L, E2 \<20 pg/mL in subjects treated with TOL2506 + tamoxifen at every measurement from Week 6 to Week 48

Percent of all subjects with LH \< 4 IU/L, E2 \<20 pg/mL in subjects treated with TOL2506 + aromatase inhibitor at every measurement from Week 6 to Week 48

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study	NCT05645536	Breast Cancer	TOL2506 Tamoxifen Letrozole table... Anastrozole Tab... Exemestane Tabl...	18 Years - 51 Years	Tolmar Inc.
Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer	NCT04906395	Breast Cancer	TOL2506 Tamoxifen Letrozole Table... Anastrozole Tab... Exemestane Tabl...	18 Years - 49 Years	Tolmar Inc.
Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study	NCT05645536	Breast Cancer	TOL2506 Tamoxifen Letrozole table... Anastrozole Tab... Exemestane Tabl...	18 Years - 51 Years	Tolmar Inc.
Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer	NCT04906395	Breast Cancer	TOL2506 Tamoxifen Letrozole Table... Anastrozole Tab... Exemestane Tabl...	18 Years - 49 Years	Tolmar Inc.

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