Study on Ovarian Suppression Using Subcutaneous Leuprolide Acetate in Breast Cancer

Sponsor: Tolmar Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04906395

Provider View

This clinical trial is testing the effectiveness and safety of a medication called TOL2506 to suppress ovarian function in premenopausal women and men with hormone receptor-positive, HER2-negative breast cancer. The study involves a screening period followed by a 48-week treatment period with either tamoxifen or aromatase inhibitors.

Patient Parameters

Program Overview

This study aims to evaluate how well TOL2506 can suppress ovarian function in premenopausal women with hormone receptor-positive, HER2-negative breast cancer. It also assesses the safety of TOL2506 in men with the same type of breast cancer. Participants will undergo a screening process to confirm their premenopausal status and eligibility. The treatment period lasts 48 weeks, during which participants will receive either tamoxifen or an aromatase inhibitor (letrozole, anastrozole, or exemestane) alongside TOL2506. Participants can switch between tamoxifen and aromatase inhibitors after 12 weeks, but not within 28 days of a dosing visit. After completing the study, participants may join a Safety Extension Study.

Eligibility Criteria

Inclusion Criteria

  • Female participants aged 18 to 49.
  • Diagnosed with Stage I, II, or III hormone receptor-positive, HER2-negative breast cancer.
  • Eligible for endocrine therapy and ovarian suppression.
  • Premenopausal status confirmed by specific hormone levels and regular menstrual cycles.
  • Able to understand the study and provide written consent.

Exclusion Criteria

  • Body mass index (BMI) less than 18 or greater than 35.
  • Currently breastfeeding.
  • Life expectancy less than 12 months.
  • Poor liver or kidney function based on specific blood tests.
  • History of abnormal heart rhythms or ECG results.
  • Recent use of medications affecting heart rhythms or bone density.
  • Previous use of certain breast cancer treatments or hormone therapies.
  • Conditions affecting bone density or recent low trauma fractures.
  • Other serious medical conditions or second malignancies.
  • Use of GnRH analogs within a year before breast cancer diagnosis.
  • Psychiatric or addictive disorders affecting study compliance.
  • Allergic reactions to study medications.
  • Not willing to use non-hormonal contraception if sexually active.
  • Positive pregnancy test or recent use of investigational drugs.

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