Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

July 1, 2021

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2026

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 or 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 (59)

5000

Instituto Oncologico de Cordoba (IONC), Córdoba

5800

Centro Privado de RMI Rio Cuarto, Río Cuarto

10461

Montefiore - Einstein Center for Cancer Care at Montefiore Medical Park, The Bronx

19096

Lankenau Medical Center, Wynnewood

20769

Maryland Oncology Hematology, P.A., Glenn Dale

37203

Tennessee Oncology, PLLC, Nashville

37404

Tennessee Oncology, PLLC, Chattanooga

40207

Baptist Health Louisville, Louisville

42202

HCG Manavata Cancer Centre, Nashik

45211

Oncology Hematology Care Clinical Trials, Cincinnati

60608

Mount Sinai Hospital, Chicago

68114

Nebraska Cancer Specialists, Omaha

75231

Texas Oncology- Dallas Presbyterian Hospital, Dallas

75702

Texas Oncology- Northeast Texas, Tyler

76800

Unidad de Medicina Especializada SMA, San Juan del Río

77598

Texas Oncology- Deke Slayton Cancer Center, Webster

78130

Texas Oncology- San Antonio, New Braunfels

78731

Texas Oncology-Austin, Austin

80138

Cypress Hematology and Oncology, Parker

91900

FAICIC S. de R.L. de C.V., Veracruz

94904

Marin Cancer Care, Inc, Greenbrae

98109

Seattle Cancer Center Alliance, Seattle

221004

Swami Harshankaranand Ji Hospital & Research Centre, Varanasi

380054

Hemato Oncology Clinic Ahmedabad Pvt. Ltd., Ahmedabad

395002

Unique Hospital Multispecialty & Research Institute, Surat

412105

Indrayani Hospital and Cancer Institute, Pune

440001

KIMS-Kingsway Hospitals, SPANV Medisearch Lifesciences, Nagpur

500096

Apollo Cancer Hospitals, Hyderabad

520002

HCG City Cancer Centre, Vijayawada

530040

Apollo Hospitals, Visakhapatnam

HCG Cancer Centre, Visakhapatnam

560027

SRV AGADI Hospital and Research Centre, Bengaluru

560072

Oncoville Cancer Hospital and Research Center, Bengaluru

570001

Mysore Medical College and Research Institute, Mysore

638012

Erode Cancer Centre Private Ltd., Erode

C1480AEB

Hospital Britanico de Buenos Aires, Buenos Aires

S2000DEJ

Instituto Medico de la Fundacion Estudios Clinicos, Rosario

S2000KDS

Hospital Provincial del Centenario, Rosario

C118AAT

Hospital Aleman, Buenos Aires

C1125ABD

Fundacion CENIT, CABA

X5000JHQ

Sanatorio Allende- Sede Nueva Cordoba, Córdoba

60135-237

Oncocentro Servicos Medicos e Hospitalares Ltda, Fortaleza

60335-480

Centro Regional Integrado de Oncologia, Fortaleza

41253-190

Hospital Sao Rafael, Salvador

74605-070

Hospital Araujo Jorge, Goiânia

79002-061

Onconeo, Campo Grande

86015-520

Hospital do Cancer de Londrina, Londrina

90610-000

Uniao Brasileira de Educacao e Assistencia, Porto Alegre

76834-899

Hospital de Amor Amazonia, Porto Velho

14784-400

Fundacao Pio XII, Barretos

09060-650

Centro de Estudos e Pesquisas de Hematologia e Oncologia da Faculdade de Medicina do ABC, Santo André

01317-001

Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria, São Paulo

90020-090

Irmamandade de Santa Casa de Misericordia de Porto Alegre, Porto Alegre

22775-001

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

M4N 3M5

Sunnybrook Odette Cancer Centre Clinical Research Program, Toronto

M5G 1Z5

Princess Margaret Cancer Centre, Toronto

07300

Amiisto Atencion Medica Integral, Investigacion Y Terapia Oncologica S.A De C.V., Mexico City

03339

Clinica EMA, Mexico City

00927

FDI Clinical Research, San Juan

All Listed Sponsors
lead

Tolmar Inc.

INDUSTRY