Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer

Running, not enrolling · Phase 3

Conditions studied: Breast Cancer

In brief

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 the safety of TOL2506 in men with HR+, HER2-negative breast cancer. The Screening Period will be conducted in two parts: 1) an abbreviated, initial screening where premenopausal status will be determined prior to neoadjuvant or adjuvant chemotherapy (if planned) and 2) the full screening assessment conducted after neoadjuvant or adjuvant chemotherapy (or for subjects who enter the study without having received chemotherapy). Following the Screening Period, eligible subjects will enter into the 48 week 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 (testosterone levels \< 50 ng/dL in males) 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 (eg, Week 24, 36, and 48 where a pre-dose blood sample for PK and PD analysis will be drawn). At the end of the Treatment Period, upon completion of the End of Study Visit (Visit 9, Week 48) subjects may be eligible to participate in a Safety Extension Study under a separate Protocol.

Key facts

Study ID

NCT04906395

Run by

Tolmar Inc.

People needed

250

Starts

2021-07-01

Expected to finish

2026-04-30

Last updated by the study team

2026-01-13

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Female
• Able to understand the investigational nature of this study and provide written informed consent prior to the participation in the trial
• Age 18 to 49, inclusive
• Diagnosis of Stage I, II, or III HR+, HER2-negative breast cancer (ER>1% and/or, PR>1%, HER2-negative per ASCO CAP guidelines)
• Is a candidate for endocrine therapy + ovarian suppression LH > 4 IU/L within 28 days prior to Day 1
• Is premenopausal as defined by:
• E2 > 30 pg/mL
• follicle stimulating hormone (FSH) < 40 IU/L
• regular menses (eg, menstrual cycle length of 21 to 35 days) Note: premenopausal status must be determined before neo/adjuvant chemotherapy in patients for which it is planned or prior to Day 1 in patients who did not have prior chemotherapy. If premenopausal status was not determined prior to chemotherapy, E2 and FSH must meet the above criteria when measured 2 weeks or more after the end of the final cycle of chemotherapy.

You may not qualify if…

• Body mass index (BMI) < 18.00 kg/m2 or > 35.00 kg/m2
• Breastfeeding
• Life expectancy < 12 months
• Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3
• Unacceptable hepatic function as determined by any of the following:
• Alanine aminotransferase (ALT) ≥ 2X upper limit of normal (ULN)
• Aspartate aminotransferase (AST) ≥ 2X ULN
• Bilirubin ≥ 2X ULN
• Alkaline phosphatase ≥ 2X ULN
• Severe hepatic impairment (Child-Pugh Class C)
• Unacceptable renal function as determined by any of the following:
• Creatinine ≥ 3X ULN
• Creatinine clearance ≤ 30 mL/minute
• Creatinine clearance ≤ 60 mL/minute in subjects with bone density 1.5 standard deviations below the young adult normal mean
• History of significantly abnormal ECG or screening 12-lead ECG demonstrating any of the following:
• HR > 100 BPM
• QRS > 120 msec
• QTc > 450 msec
• PR > 220 msec
• Prior (within 28 days prior to Day 1) and/or concomitant use of medications known to prolong the QT/QTc interval
• Prior use of tamoxifen, other SERMs (eg, raloxifene) or antagonists (eg, fulvestrant), aromatase inhibitor, mammalian target of rapamycin (mTOR) inhibitors, or hormone replacement therapy within 3 months before breast cancer diagnosis
• Concomitant use of anticancer mediations other than those specified for use by the protocol
• Prior neoadjuvant or adjuvant endocrine therapy since diagnosis of breast cancer
• History of treatment for osteopenia/osteoporosis or baseline bone mineral density Z-score ≤ -2.0
• Prior (within 6 months prior to Day 1) or current use of drugs known to increase bone mineral density (ie, bisphosphonates, denosumab, teriparatide, abaloparatide, romosozumab) or use of supplements known to increase bone mineral density (ie, calcitonin, fluoride, strontium) within 28 days prior to Day 1

Where it is running

• Cypress Hematology and Oncology — Parker, Colorado, United States
• Mount Sinai Hospital — Chicago, Illinois, United States
• Baptist Health Louisville — Louisville, Kentucky, United States
• Maryland Oncology Hematology, P.A. — Glenn Dale, Maryland, United States
• Nebraska Cancer Specialists — Omaha, Nebraska, United States
• Montefiore - Einstein Center for Cancer Care at Montefiore Medical Park — The Bronx, New York, United States
• Oncology Hematology Care Clinical Trials — Cincinnati, Ohio, United States
• Lankenau Medical Center — Wynnewood, Pennsylvania, United States
• Tennessee Oncology, PLLC — Chattanooga, Tennessee, United States
• Tennessee Oncology, PLLC — Nashville, Tennessee, United States
• Texas Oncology-Austin — Austin, Texas, United States
• Texas Oncology- Dallas Presbyterian Hospital — Dallas, Texas, United States
• Texas Oncology- San Antonio — New Braunfels, Texas, United States
• Texas Oncology- Northeast Texas — Tyler, Texas, United States
• Texas Oncology- Deke Slayton Cancer Center — Webster, Texas, United States
• Seattle Cancer Center Alliance — Seattle, Washington, United States
• Hospital Britanico de Buenos Aires — Buenos Aires, Buenos Aires F.D., Argentina
• Instituto Oncologico de Cordoba (IONC) — Córdoba, Córdoba Province, Argentina
• Centro Privado de RMI Rio Cuarto — Río Cuarto, Córdoba Province, Argentina
• Instituto Medico de la Fundacion Estudios Clinicos — Rosario, Santa Fe Province, Argentina
• Hospital Provincial del Centenario — Rosario, Santa Fe Province, Argentina
• Hospital Aleman — Buenos Aires, Argentina
• Fundacion CENIT — CABA, Argentina
• Sanatorio Allende- Sede Nueva Cordoba — Córdoba, Argentina
• Marin Cancer Care, Inc — Greenbrae, California, United States

Full record on ClinicalTrials.gov

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