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

  • STATUS
    Not Recruiting
  • sponsor
    Tolmar Inc.
Updated on 4 October 2022
endocrine therapy
hormone therapy
HER2
tamoxifen
estradiol
erbb2
anastrozole
exemestane
letrozole
her2/neu-negative breast cancer

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.

Description

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

Details
Condition Breast Cancer
Clinical Study IdentifierTX290231
SponsorTolmar Inc.
Last Modified on4 October 2022

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