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

NCT ID: NCT02600923

Last Updated: 2022-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-15
• Study Completion Date: 2019-05-28

Brief Summary

The purpose of this study is to provide access to palbociclib in Mexico and in selected Latin American countries before it becomes commercially available to patients with HR positive/HER2-negative ABC who are appropriate candidates for letrozole therapy.

Conditions

Advanced Breast Cancer Female

Study Design

• Allocation Method: NA
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Palbociclib + Letrozole

palbociclib and letrozole combination

Group Type: EXPERIMENTAL

Palbociclib

Intervention Type: DRUG

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).

Letrozole

Intervention Type: DRUG

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Ibrance; Femara

Eligibility Criteria

Inclusion Criteria

• Adult women with proven diagnosis of advanced adenocarcinoma of the breast (locoregional recurrent or metastatic disease).
• Women who are not of childbearing potential.
• ER-positive and/or Progesterone receptor (PgR)-positive tumor based on local laboratory results (test as per local practice).
• HER2-negative breast cancer based on local laboratory results (test as per local practice or local guidelines).
• Patients must be appropriate candidates for letrozole therapy.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Adequate bone marrow function.
• Adequate liver function
• Adequate renal function.

Exclusion Criteria

• Known hypersensitivity to letrozole, or any of its excipients, or to any palbociclib excipients.
• Current use of food or drugs known to be potent inhibitors or inducers of CYP3A4 isoenzymes within 7 days prior to study entry.
• Prior treatment with any CDK inhibitor.
• Previous participation in a palbociclib clinical study.
• Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry and/or during study participation.
• QTc >480 msec; history of QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes.
• High cardiovascular risk, including, but not limited to recent myocardial infarction, severe/unstable angina and severe cardiac dysrhythmias in the past 6 months prior to enrollment.
• Diagnosis of any second invasive malignancy within the last 3 years prior to enrollment. Note: patients with adequately treated basal cell or squamous cell skin cancer, a history of intraepithelial neoplasia or in situ disease (eg, carcinoma in situ of the cervix or melanoma in situ) may enter.
• Active uncontrolled or symptomatic brain metastases. Previously treated and clinically stable, brain metastases are permitted.
• Other severe acute or chronic medical or psychiatric conditions.
• Patients who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees directly involved in the conduct of the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Instituto de Oncologia de Rosario

Rosario, Santa Fe Province, Argentina

Sanatorio Guemes

CABA, , Argentina

Hospital Italiano de Buenos Aires

CABA, , Argentina

Hospital Britanico de Buenos Aires

CABA, , Argentina

Instituto Medico Especializado Alexander Fleming

CABA, , Argentina

Instituto de Cardiologia y Cirugia Cardiovascular

Santa Fe, , Argentina

ISIS Centro Especializado

Santa Fe, , Argentina

Hospital Da Cidade De Passo Fundo

Passo Fundo, Rio Grande do Sul, Brazil

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

Porto Alegre, Rio Grande do Sul, Brazil

Oncologia Rede D'Or S.A.

Rio de Janeiro, , Brazil

IDOR - Instituto D'Or em Pesquisa e Ensino

Rio de Janeiro, , Brazil

Sociedade Beneficente de Senhoras Hospital Sirio Libanes

São Paulo, , Brazil

Clínica de Pesquisa e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda

São Paulo, , Brazil

Instituto de Cancerologia S.A.

Medellín, Antioquia, Colombia

Administradora Country

Bogotá, Bogota D.C., Colombia

Oncology Center

Bogotá, Bogota D.C., Colombia

Oncomedica S.A.

Montería, Departamento de Córdoba, Colombia

Imagenes Diagnosticas

Pereira, Risaralda Department, Colombia

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

Pereira, Risaralda Department, Colombia

Fucam A.C.

Coyoacán, D.F., Mexico

Instituto Nacional de Cancerologia

Tlalpan, D.F., Mexico

Hospital Maria Auxiliadora

Guadalajara, Jalisco, Mexico

Clinica de Especialidades Medicas Intepro, ONCE Oncologia Especializada

Zapopan, Jalisco, Mexico

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, Nuevo León, Mexico

Countries

Argentina; Brazil; Colombia; Mexico

References

Fein L, Lazaretti N, Chuken YL, Benfield JRGR, Mano MS, Lobaton J, Korbenfeld E, Damian F, Lu DR, Mori A, Patyna SJ, Franco S. Expanded Access Study of Palbociclib Plus Letrozole for Postmenopausal Women with HR+/HER2- Advanced Breast Cancer in Latin America for Whom Letrozole Therapy is Deemed Appropriate. Clin Drug Investig. 2023 Sep;43(9):699-706. doi: 10.1007/s40261-023-01294-3. Epub 2023 Aug 18.

Reference Type: DERIVED

PMID: 37594640 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=A5481053

To obtain contact information for a study center near you, click here.

Other Identifiers

A5481053

Identifier Type: -

Identifier Source: org_study_id