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.

Elegibilidad

Edad mínima: 18 YearsSexo: FEMALE

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

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).

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.

Ubicaciones

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

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

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Palbociclib

Letrozole

Ubicaciones

Instituto de Oncologia de Rosario

Sanatorio Guemes

Hospital Italiano de Buenos Aires

Hospital Britanico de Buenos Aires

Instituto Medico Especializado Alexander Fleming

Instituto de Cardiologia y Cirugia Cardiovascular

ISIS Centro Especializado

Patrocinadores