Palbociclib Plus Letrozole For Postmenopausal Women With HR(+) HER2(-) Advanced Breast Cancer For Whom Letrozole Is Deemed Appropriate

PHASE3CompletedINTERVENTIONAL
Enrollment

131

Participants

Timeline

Start Date

April 15, 2016

Primary Completion Date

May 28, 2019

Study Completion Date

May 28, 2019

Conditions
Advanced Breast Cancer Female
Interventions
DRUG

Palbociclib

Palbociclib will be administered orally once a day at 125 mg/day for 21 days followed by 7 days off treatment for each 28-day cycle (Schedule 3/1).

DRUG

Letrozole

Letrozole will be administered orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information.

Trial Locations (24)

14080

Instituto Nacional de Cancerologia, Tlalpan

44540

Hospital Maria Auxiliadora, Guadalajara

45030

Clinica de Especialidades Medicas Intepro, ONCE Oncologia Especializada, Zapopan

64460

Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey

230003

Oncomedica S.A., Montería

660001

Imagenes Diagnosticas, Pereira

ONCOLOGOS DEL OCCIDENTE S.A.S Sede Pereira Clinica de Alta Tecnologia Maraya, Pereira

11001000

Administradora Country, Bogotá

110221162

Oncology Center, Bogotá

S2000KZE

Instituto de Oncologia de Rosario, Rosario

C1180AAX

Sanatorio Guemes, CABA

C1181ACH

Hospital Italiano de Buenos Aires, CABA

C1280AEB

Hospital Britanico de Buenos Aires, CABA

C1426ANZ

Instituto Medico Especializado Alexander Fleming, CABA

S3000EPV

Instituto de Cardiologia y Cirugia Cardiovascular, Santa Fe

S3000FFU

ISIS Centro Especializado, Santa Fe

99010-260

Hospital Da Cidade De Passo Fundo, Passo Fundo

90610-000

Hospital Sao Lucas da PUCRS / Uniao Brasileira de Educacao e Assistencia, Porto Alegre

22271-110

Oncologia Rede D'Or S.A., Rio de Janeiro

22281-100

IDOR - Instituto D'Or em Pesquisa e Ensino, Rio de Janeiro

01308-050

Sociedade Beneficente de Senhoras Hospital Sirio Libanes, São Paulo

01317-000

Clínica de Pesquisa e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda, São Paulo

050034

Instituto de Cancerologia S.A., Medellín

04890

Fucam A.C., Coyoacán

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT02600923 - Palbociclib Plus Letrozole For Postmenopausal Women With HR(+) HER2(-) Advanced Breast Cancer For Whom Letrozole Is Deemed Appropriate | Biotech Hunter | Biotech Hunter