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Two Different Schedules of Palbociclib + Second Line Endocrine Therapy in Estrogen Receptor Positive, HER2 Neg Advanced/Metastatic Breast Cancer

NCT02630693 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-04-13

Study results available
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Summary

The purpose of this study is to determine if the combination of endocrine therapy and Palbociclib at a daily dose of 100 mg will result in a better response to therapy with fewer dose interruptions than the proposed dosing regimen of 125 mg daily for 21 days out of a 28 day cycle in combination with endocrine therapy.

Conditions

Interventions

DRUG

Palbociclib 100mg

100mg PO daily

DRUG

Palbociclib 125mg

125mg PO daily 3 weeks out of 4

DRUG

Fulvestrant or Tamoxifen or Aromatase Inhibitor

given at the standard doses/schedules

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Canadian Cancer Trials Group

    lead NETWORK

Principal Investigators

  • Anil A. Joy · Cross Cancer Institute, Edmonton Alberta Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-08
Primary Completion
2018-08-15
Completion
2023-11-29

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02630693 on ClinicalTrials.gov