Clinical trial NCT02600923: Palbociclib Plus Letrozole For Postmenopausal Women With HR(+) HER2(-) Advanced Breast Cancer For Whom Letrozole Is Deemed Appropriate
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Advanced Breast Cancer Female
Keywords: palbociclib, ibrance, breast cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-11-09
Enrollment: 131
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs)
timeFrame: 3 years
measure: Number of Participants With Palbociclib-related TEAEs
timeFrame: 3 years
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: 3 years
Secondary outcomes:
measure: Number of Participants With Death
timeFrame: 3 years
measure: The Objective Response Rate (ORR)
timeFrame: 3 years
Other outcomes:
Locations:
city: Rosario
country: Argentina
facility: Instituto de Oncologia de Rosario
state: Santa FE
city: Caba
country: Argentina
facility: Sanatorio Guemes
city: Caba
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Caba
country: Argentina
facility: Hospital Britanico de Buenos Aires
city: Caba
country: Argentina
facility: Instituto Medico Especializado Alexander Fleming
city: Santa Fe
country: Argentina
facility: Instituto de Cardiologia y Cirugia Cardiovascular
city: Santa Fe
country: Argentina
facility: ISIS Centro Especializado
city: Passo Fundo
country: Brazil
facility: Hospital Da Cidade De Passo Fundo
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUCRS / Uniao Brasileira de Educacao e Assistencia
state: RIO Grande DO SUL
city: Rio de Janeiro
country: Brazil
facility: Oncologia Rede D'Or S.A.
city: Rio de Janeiro
country: Brazil
facility: IDOR - Instituto D'Or em Pesquisa e Ensino
city: Sao Paulo
country: Brazil
facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes
city: São Paulo
country: Brazil
facility: Clínica de Pesquisa e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda
city: Medellin
country: Colombia
facility: Instituto de Cancerologia S.A.
state: Antioquia
city: Monteria
country: Colombia
facility: Oncomedica S.A.
state: Cordoba
city: Bogota
country: Colombia
facility: Administradora Country
state: Distrito Capital
city: Bogota
country: Colombia
facility: Oncology Center
state: Distrito Capital
city: Pereira
country: Colombia
facility: Imagenes Diagnosticas
state: Risaralda
city: Pereira
country: Colombia
facility: ONCOLOGOS DEL OCCIDENTE S.A.S Sede Pereira Clinica de Alta Tecnologia Maraya
state: Risaralda
city: Coyoacan
country: Mexico
facility: Fucam A.C.
state: D.f.
city: Tlalpan
country: Mexico
facility: Instituto Nacional de Cancerologia
state: D.f.
city: Guadalajara
country: Mexico
facility: Hospital Maria Auxiliadora
state: Jalisco
city: Zapopan
country: Mexico
facility: Clinica de Especialidades Medicas Intepro, ONCE Oncologia Especializada
state: Jalisco
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez
state: Nuevo LEON
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: