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

NCT02600923 | Completed Phase 3 Results

• 1 other identifier: A5481053
• Study Type: interventional
• Target: 131
• Locations: 4 countries
• Sites: 24

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

Keywords

palbociclib, ibrance, breast cancer

Outcome Measures

Primary Outcomes (3)

• Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs)

  An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. All AEs reported after initiation of study drug treatment were considered as TEAE. AE severity was graded according to Common Terminology Criteria for AEs (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity.

  3 years

• Number of Participants With Palbociclib-related TEAEs

  An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. All AEs reported after initiation of study drug treatment were considered as TEAE. AE severity was graded according to CTCAE version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Palbociclib-related TEAEs were determined by the investigator.

  3 years

• Number of Participants With Serious Adverse Events (SAEs)

  An SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and AEs. Palbociclib-related SAEs were determined by the investigator.

  3 years

Secondary Outcomes (2)

• Number of Participants With Death

  3 years

• The Objective Response Rate (ORR)

  3 years

Study Arms (1)

Palbociclib + Letrozole

EXPERIMENTAL

palbociclib and letrozole combination

Drug: Palbociclib; Drug: Letrozole

Interventions

Palbociclib 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).

Also known as: Ibrance

Palbociclib + Letrozole

Letrozole 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.

Also known as: Femara

Palbociclib + Letrozole

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (24)

Instituto de Oncologia de Rosario

Rosario, Santa Fe Province, S2000KZE, Argentina

Location

Sanatorio Guemes

CABA, C1180AAX, Argentina

Location

Hospital Italiano de Buenos Aires

CABA, C1181ACH, Argentina

Location

Hospital Britanico de Buenos Aires

CABA, C1280AEB, Argentina

Location

Instituto Medico Especializado Alexander Fleming

CABA, C1426ANZ, Argentina

Location

Instituto de Cardiologia y Cirugia Cardiovascular

Santa Fe, S3000EPV, Argentina

Location

ISIS Centro Especializado

Santa Fe, S3000FFU, Argentina

Location

Hospital Da Cidade De Passo Fundo

Passo Fundo, Rio Grande do Sul, 99010-260, Brazil

Location

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

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Oncologia Rede D'Or S.A.

Rio de Janeiro, 22271-110, Brazil

Location

IDOR - Instituto D'Or em Pesquisa e Ensino

Rio de Janeiro, 22281-100, Brazil

Location

Sociedade Beneficente de Senhoras Hospital Sirio Libanes

São Paulo, 01308-050, Brazil

Location

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

São Paulo, 01317-000, Brazil

Location

Instituto de Cancerologia S.A.

Medellín, Antioquia, 050034, Colombia

Location

Administradora Country

Bogotá, Bogota D.C., 11001000, Colombia

Location

Oncology Center

Bogotá, Bogota D.C., 110221162, Colombia

Location

Oncomedica S.A.

Montería, Departamento de Córdoba, 230003, Colombia

Location

Imagenes Diagnosticas

Pereira, Risaralda Department, 660001, Colombia

Location

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

Pereira, Risaralda Department, 660001, Colombia

Location

Fucam A.C.

Coyoacán, D.F., 04890, Mexico

Location

Instituto Nacional de Cancerologia

Tlalpan, D.F., 14080, Mexico

Location

Hospital Maria Auxiliadora

Guadalajara, Jalisco, 44540, Mexico

Location

Clinica de Especialidades Medicas Intepro, ONCE Oncologia Especializada

Zapopan, Jalisco, 45030, Mexico

Location

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (1)

• 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.

  PMID: 37594640 DERIVED

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib; Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2015
• First Posted: November 9, 2015
• Study Start: April 15, 2016
• Primary Completion: May 28, 2019
• Study Completion: May 28, 2019
• Last Updated: January 20, 2022
• Results First Posted: May 21, 2020

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share

Locations

CO (6); BR (6); AR (7); ME (5)