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

STUDY OF PALBOCICLIB IN COMBINATION WITH LETROZOLE AS TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER FOR WHOM LETROZOLE THERAPY IS DEEMED APPROPRIATE

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.

Study Overview

• Status: Completed
• Conditions: Advanced Breast Cancer Female
• Intervention / Treatment: Drug: Palbociclib; Drug: Letrozole

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina, C1280AEB
    • Hospital Britanico de Buenos Aires
  • Caba, Argentina, C1180AAX
    • Sanatorio Güemes
  • Caba, Argentina, C1181ACH
    • Hospital Italiano de Buenos Aires
  • Caba, Argentina, C1426ANZ
    • Instituto Médico Especializado Alexander Fleming
  • Santa Fe, Argentina, S3000FFU
    • ISIS Centro especializado
  • Santa Fe, Argentina, S3000EPV
    • Instituto de Cardiología y Cirugía Cardiovascular
  • Santa FE
    • Rosario, Santa FE, Argentina, S2000KZE
      • Instituto de Oncologia de Rosario
• Brazil
  • Rio de Janeiro, Brazil, 22271-110
    • Oncologia Rede D'Or S.A.
  • Rio de Janeiro, Brazil, 22281-100
    • IDOR - Instituto D'Or em Pesquisa e Ensino
  • Sao Paulo, Brazil, 01308-050
    • Sociedade Beneficente de Senhoras Hospital Sirio Libanes
  • São Paulo, Brazil, 01317-000
    • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
  • RIO Grande DO SUL
    • Passo Fundo, RIO Grande DO SUL, Brazil, 99010-260
      • Hospital da Cidade de Passo Fundo
    • Porto Alegre, RIO Grande DO SUL, Brazil, 90610-000
      • Hospital Sao Lucas da PUCRS / Uniao Brasileira de Educacao e Assistencia
• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia, 050034
      • Instituto de Cancerologia S.A.
  • Cordoba
    • Monteria, Cordoba, Colombia, 230003
      • Oncomedica S.A.
  • Distrito Capital
    • Bogota, Distrito Capital, Colombia, 11001000
      • Administradora Country
    • Bogota, Distrito Capital, Colombia, 110221162
      • Oncology Center
  • Risaralda
    • Pereira, Risaralda, Colombia, 660001
      • Imagenes Diagnosticas
    • Pereira, Risaralda, Colombia, 660001
      • ONCOLOGOS DEL OCCIDENTE S.A.S Sede Pereira Clinica de Alta Tecnologia Maraya
• Mexico
  • D.f.
    • Coyoacan, D.f., Mexico, 04890
      • Fucam A.C.
    • Tlalpan, D.f., Mexico, 14080
      • Instituto Nacional de Cancerologia
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44540
      • Hospital Maria Auxiliadora
    • Zapopan, Jalisco, Mexico, 45030
      • Clinica de Especialidades Medicas Intepro, ONCE Oncologia Especializada
  • Nuevo LEON
    • Monterrey, Nuevo LEON, Mexico, 64460
      • Hospital Universitario Dr. José Eleuterio González

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Palbociclib + Letrozole; palbociclib and letrozole combination

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).; Other Names: Ibrance; 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.; Other Names: Femara

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Death	Death from any cause while on treatment and within 28 days of palbociclib discontinuation was only counted below.	3 years
The Objective Response Rate (ORR)	The tumor response was based on the response reported by investigator per local practice. No response confirmation was applied. ORR was defined as the percentage of participants with complete response or partial response relative to all as-treated population.	3 years

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2016
• Primary Completion (Actual): May 28, 2019
• Study Completion (Actual): May 28, 2019

Study Registration Dates

• First Submitted: November 6, 2015
• First Submitted That Met QC Criteria: November 6, 2015
• First Posted (Estimate): November 9, 2015

Study Record Updates

• Last Update Posted (Actual): January 20, 2022
• Last Update Submitted That Met QC Criteria: January 18, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: palbociclib, ibrance, breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Protein Kinase Inhibitors; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Letrozole; Palbociclib
• Other Study ID Numbers: A5481053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.