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

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ClinicalTrials.gov Identifier: NCT02600923
Recruitment Status : Completed
First Posted : November 9, 2015
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Advanced Breast Cancer Female Drug: Palbociclib Drug: Letrozole Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 15, 2016
Actual Primary Completion Date : May 28, 2019
Actual Study Completion Date : May 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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 Name: 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 Name: Femara




Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment [ Time Frame: Baseline up to 28 days after last dose of study treatment ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.


Secondary Outcome Measures :
  1. Objective Response (OR) [ Time Frame: At Screening and per routine clinical practice to time of last dose of study treatment, up to 30 months. ]
    Number of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02600923


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

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02600923     History of Changes
Other Study ID Numbers: A5481053
First Posted: November 9, 2015    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Keywords provided by Pfizer:
palbociclib, ibrance, breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Palbociclib
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Protein Kinase Inhibitors