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

Part of paid clinical trials in Greenbrae, California.

Sponsor
Tolmar Inc.
Study ID
NCT05645536
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 51 Years
Healthy Volunteers
Not accepted

Interventions

  • TOL2506 — DRUG
    Leuprolide Acetate for injectable suspension, 30 mg. Subcutaneous injection every 3 months
  • Tamoxifen — DRUG
    20 mg once daily or 10 mg 2 times daily - either tablet of solution
  • Letrozole tablets — DRUG
    One 2.5 mg tablet taken orally once daily
  • Anastrozole Tablets — DRUG
    One 1 mg tablet taken orally once daily
  • Exemestane Tablets — DRUG
    One 25 mg tablet taken orally once daily

Study Details

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.

Key Dates

Start date
Dec 28, 2022
Status verified
Apr 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
250 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

The occurrences of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) [ Time Frame: 4 years from enrolling in study ]

Locations (17)

FacilityCityStateZIPSite coordinators
Marin Cancer Care, Inc.GreenbraeCalifornia94904-
Holy Cross HospitalFort LauderdaleFlorida33308-
Baptist Health LexingtonLexingtonKentucky40503-
Baptist Health LouisvilleLouisvilleKentucky40207-
Maryland Oncology Hematology, P.A.ColumbiaMaryland21044-
Hematology Oncology Associates of Central New York, PCEast SyracuseNew York13057-
Cape Fear Valley Health Systems - Cancer CenterFayettevilleNorth Carolina28304-
Lankenau Medical CenterWynnewoodPennsylvania19096-
Tennessee Oncology, PLLCChattanoogaTennessee37404-
Tennessee OncologyNashvilleTennessee37203-
Texas Oncology - Central SouthAustinTexas78745-
Texas Oncology - Presbyterian Cancer CenterDallasTexas75231-
Texas Oncology - Northeast TexasLongviewTexas75601-
Joe Arrington Cancer Research and Treatment Center at Covenant Children's HospitalLubbockTexas79410-
Texas Oncology - San AntonioNew BraunfelsTexas78130-
Texas Oncology - DFWPlanoTexas75075-
Fred Hutchinson Cancer CenterSeattleWashington98109-

Find similar trials in Greenbrae, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Marin Cancer Care, Inc.· Greenbrae, CAHoly Cross Hospital· Fort Lauderdale, FLBaptist Health Lexington· Lexington, KYBaptist Health Louisville· Louisville, KYMaryland Oncology Hematology, P.A.· Columbia, MDHematology Oncology Associates of Central New York, PC· East Syracuse, NY

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