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

PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

December 28, 2022

Primary Completion Date

June 30, 2028

Study Completion Date

June 30, 2028

Conditions
Breast Cancer
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

Trial Locations (43)

5000

Instituto Oncologico de Cordoba (IONC), Córdoba

13057

Hematology Oncology Associates of Central New York, PC, East Syracuse

19096

Lankenau Medical Center, Wynnewood

21044

Maryland Oncology Hematology, P.A., Columbia

28304

Cape Fear Valley Health Systems - Cancer Center, Fayetteville

33308

Holy Cross Hospital, Fort Lauderdale

37203

Tennessee Oncology, Nashville

37404

Tennessee Oncology, PLLC, Chattanooga

40207

Baptist Health Louisville, Louisville

40503

Baptist Health Lexington, Lexington

44340

CIMET Scientific Corporation S. A. P. I. de C. V., Guadalajara

75075

Texas Oncology - DFW, Plano

75231

Texas Oncology - Presbyterian Cancer Center, Dallas

75601

Texas Oncology - Northeast Texas, Longview

78130

Texas Oncology - San Antonio, New Braunfels

78745

Texas Oncology - Central South, Austin

79410

Joe Arrington Cancer Research and Treatment Center at Covenant Children's Hospital, Lubbock

86015

Hospital do Cancer de Londrina, Londrina

91900

Faicic S de Rl de C. V., Veracruz

94904

Marin Cancer Care, Inc., Greenbrae

98109

Fred Hutchinson Cancer Center, Seattle

221005

Swami Harshankaranand Ji Hospital & Research Centre, Varanasi

412105

Indrayani Hospital and Cancer Institute, Pune

440001

KIMS - Kingsway Hospitals, Nagpur

560027

SRV AGADI Hospital and Research Centre, Bangalore

560072

Oncoville Cancer Hospital and Research Centre, Bengaluru

570001

Mysore Medical College and Research Institute, Mysore

638012

Erode Cancer Centre Private Ltd., Erode

S2000DEJ

Instituto Medico de la Fundacion Estudios Clinicos, Rosario

C1118AAT

Hospital Aleman, Caba

C1125ABD

Fundacion CENIT, CABA

X5800

Centro Privado de MRI de Rio Cuarto SA, Córdoba

Unknown

Sanatorio Allende, Córdoba

Centro de Estudos e Pesquisa de Hematologia e Oncologia, Santo André

Amiisto Atencion Medica Integral, Investigacion Y Terapia Oncologica S. A. DE C. V., Madero

60335-480

Centro Regional Integrado de Oncologia, Fortaleza

74605-070

Hospital Araujo Jorge, Goiânia

90050-170

Irmandade Santa Casa de Misericordia de Porto Alegre, Porto Alegre

76834-899

Hospital de Amor Amazonia, Porto Velho

22775-001

Instituto de Educacao, Pesquisa e Gestao em Saude, Rio de Janeiro

14784-070

Fundacao Pio XII - Hospital de Amor Barretos, São Paulo

07300

Atencion Medica Integral E Investigacion en Terapia Oncologica, Mexico City

00927

FDI Clinical Research, San Juan

All Listed Sponsors
lead

Tolmar Inc.

INDUSTRY