Clinical Trials /

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

NCT02600923

Description:

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.

Related Conditions:
  • Breast Adenocarcinoma
Recruiting Status:

Completed

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: A5481053
  • NCT ID: NCT02600923

Conditions

  • Advanced Breast Cancer Female

Interventions

DrugSynonymsArms
PalbociclibIbrancePalbociclib + Letrozole
LetrozoleFemaraPalbociclib + Letrozole

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Palbociclib + LetrozoleExperimentalpalbociclib and letrozole combination
  • Palbociclib
  • Letrozole

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description: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

Measure:Objective Response (OR)
Time Frame:At Screening and per routine clinical practice to time of last dose of study treatment, up to 30 months.
Safety Issue:
Description: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.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Pfizer

Trial Keywords

  • palbociclib, ibrance, breast cancer

Last Updated

February 9, 2018