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

Official title

Open-label, Safety Extension Study for Subjects With HR+, HER2-Negative Breast Cancer Who Have Completed the OVarian Suppression Evaluating Subcutaneous LeuprolIde Acetate in Breast Cancer OVELIA Study

Overview

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.

Interventions

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

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

Females:

• Completed Visit 9, Week 48 visit of TOL2506A study and is a candidate for continued endocrine therapy + ovarian suppression
• Able to understand the investigational nature of this study and provide written informed consent prior to the participation in the trial
• Age 18 to 51 inclusive

Exclusion criteria

• Females:

• Body mass index (BMI) < 18.00 kg/m2
• Life expectancy < 12 months
• 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
• Screening 12-lead ECG demonstrating any of the following:

• Heart rate > 100 beats per minute (BPM)
• QRS > 120 msec
• Corrected QT (QTc) > 450 msec
• PR > 220 msec
• Use of any new medications known to prolong the QT/QTc interval
• Any new medical condition or psychiatric, addictive or other disorder that, in the opinion of the Investigator, may interfere with trial conduct or result in the subject being ineligible to continue treatment with TOL2506
• Concomitant use of medications that may impact subject safety including but not limited to:

• Oral or transdermal hormonal therapy
• Estrogen, progesterone, or androgens
• Hormonal contraceptives
• Change in tolerability to TOL2506 that precludes continued treatment
• Sexually active with a male partner and not willing to use at least 2 non-hormonal contraceptive methods throughout the study
• Is of childbearing potential with a positive urine pregnancy test at Screening

Males:

Inclusion criteria

• Completed Visit 9, Week 48 visit of TOL2506A study and is a candidate for continued endocrine + GnRH agonist therapy
• Able to understand the investigational nature of this study and provide written informed consent prior to participation in the trial

Males:

Exclusion criteria

• BMI < 18.00 kg/m2
• Life expectancy < 12 months
• ECOG performance status ≥ 3
• Unacceptable hepatic function as determined by any of the following:

• ALT ≥ 2X ULN
• 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
• Screening 12-lead ECG demonstrating any of the following:

• HR > 100 BPM
• QRS > 120 msec
• QTc > 450 msec
• PR > 220 msec
• Use of any new medications known to prolong the QT/QTc interval
• Any new medical condition or psychiatric, addictive or other disorder that, in the opinion of the Investigator, may interfere with trial conduct or result in the subject being ineligible to continue treatment with TOL2506
• Concomitant use of medications that may impact subject safety including but not limited to oral or transdermal hormonal therapy
• Change in tolerability to TOL2506 that precludes continued treatment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 17 centers

• Marin Cancer Care, Inc. — Greenbrae
• Holy Cross Hospital — Fort Lauderdale
• Baptist Health Lexington — Lexington
• Baptist Health Louisville — Louisville
• Maryland Oncology Hematology, P.A. — Columbia
• Hematology Oncology Associates of Central New York, PC — East Syracuse
• Cape Fear Valley Health Systems - Cancer Center — Fayetteville
• Lankenau Medical Center — Wynnewood
• … and 9 more centers

Brazil · 9 centers

• Centro Regional Integrado de Oncologia — Fortaleza
• Hospital Araujo Jorge — Goiânia
• Hospital do Cancer de Londrina — Londrina
• Irmandade Santa Casa de Misericordia de Porto Alegre — Porto Alegre
• Uniao Brasileira de Educacao e Assistencia — Porto Alegre
• Hospital de Amor Amazonia — Porto Velho
• Instituto de Educacao, Pesquisa e Gestao em Saude — Rio de Janeiro
• Centro de Estudos e Pesquisa de Hematologia e Oncologia — Santo André
• … and 1 more center

India · 9 centers

• Unique Hospital Multispecialty & Research Institute — Surat
• SRV AGADI Hospital and Research Centre — Bangalore
• Oncoville Cancer Hospital and Research Centre — Bengaluru
• Mysore Medical College and Research Institute — Mysore
• KIMS - Kingsway Hospitals — Nagpur
• HCG Manavata Cancer Centre — Nashik
• Indrayani Hospital and Cancer Institute — Pune
• Erode Cancer Centre Private Ltd. — Erode
• … and 1 more center

Argentina · 6 centers

• Instituto Medico de la Fundacion Estudios Clinicos — Rosario
• Hospital Aleman — Caba
• Fundacion CENIT — CABA
• Instituto Oncologico de Cordoba (IONC) — Córdoba
• Centro Privado de MRI de Rio Cuarto SA — Córdoba
• Sanatorio Allende — Córdoba

Mexico · 5 centers

• Unidad de Medicina Especializada SMA — San Juan del Río
• CIMET Scientific Corporation S. A. P. I. de C. V. — Guadalajara
• Amiisto Atencion Medica Integral, Investigacion Y Terapia Oncologica S. A. DE C. V. — Madero
• Atencion Medica Integral E Investigacion en Terapia Oncologica — Mexico City
• Faicic S de Rl de C. V. — Veracruz

Puerto Rico · 1 center

• FDI Clinical Research — San Juan

Identifiers

NCT: NCT05645536 · TOL2506A-EXT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗