Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
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 administration of TOL2506 in men with HR+ breast cancer. Study
duration, for individual subjects, will be up to 57 weeks, including a Screening Period of up
to 9 weeks, a Treatment Period of 48 weeks, and an End of Study Visit (Visit 8, Week 48).
Eligible subjects will enter into the 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 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. At the end of the Treatment Period, subjects will
be eligible for compassionate use of TOL2506 (expanded access) until TOL2506 receives
marketing approval and is commercially available.