TOL2506A: A Phase 3, Single Arm, Open-Label Study Evaluating Ovarian Suppression Following Three-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
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.
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
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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