Clinical Trials /

Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer

NCT02679755

Description:

A study of palbociclib in combination with letrozole as treatment of post-menopausal women with hormone receptor-positive, her2-negative advanced breast cancer for whom letrozole therapy is deemed appropriate.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 4

Trial Eligibility

Document

Title

  • Brief Title: Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer
  • Official Title: A Study Of Palbociclib In Combination With Letrozole As Treatment Of Post-menopausal Women With Hormone Receptor-positive, Her2-negative Advanced Breast Cancer For Whom Letrozole Therapy Is Deemed Appropriate

Clinical Trial IDs

  • ORG STUDY ID: A5481037
  • NCT ID: NCT02679755

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
PalbociclibIBRANCEExperimental arm
LetrozoleExperimental arm

Purpose

A study of palbociclib in combination with letrozole as treatment of post-menopausal women with hormone receptor-positive, her2-negative advanced breast cancer for whom letrozole therapy is deemed appropriate.

Detailed Description

      To provide access to palbociclib to post-menopausal patients with hormone receptor-positive
      [HR(+)], HER2-negative [HER2(-)] ABC who are deemed appropriate for letrozole therapy.
    

Trial Arms

NameTypeDescriptionInterventions
Experimental armExperimentalPalbociclib plus Letrozole
  • Palbociclib
  • Letrozole

Eligibility Criteria

        Inclusion Criteria:

          -  Post-menopausal women (>=18 years of age) with proven diagnosis of advanced carcinoma
             of the breast (ER(+) and/or PgR(+) and HER2(-)) who are appropriate for letrozole
             therapy (in the first-line advanced/metastatic disease setting).

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

          -  Adequate bone marrow, liver, and renal function.

        Exclusion Criteria:

          -  Prior treatment with any CDK inhibitor .

          -  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 myocardial infarction,
             severe/unstable angina, severe cardiac dysrhythmias, and symptomatic pulmonary
             embolism in the past 6 months of enrollment.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Percentage of patients with treatment-emergent averse events (AEs) or serious adverse events (SAEs)
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
Time Frame:Baseline and per routine clinical practice to time of last dose of study treatment, up to 24 months
Safety Issue:
Description:Number of patients with objective response (complete response or partial response)
Measure:Change from Baseline in Dimension Health State EuroQol (EQ-5D) Score
Time Frame:Baseline, Day 1 of each cycle up to 3 years
Safety Issue:
Description:EQ-5D is a standard, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care,, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weighs each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). [Australia only]

Details

Phase:Phase 4
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Pfizer

Trial Keywords

  • Hormone receptor positive advanced breast cancer

Last Updated

April 13, 2018