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Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Advanced Breast Cancer

NCT02491983 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 486

Last updated 2024-12-09

Study results available
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Summary

This is an international, randomized, open-label, controlled, multicenter phase II clinical trial to investigate and compare the safety and efficacy of palbociclib combined with fulvestrant or letrozole in women with ER+, HER2- locally advanced or metastatic breast cancer.

Conditions

Interventions

DRUG

Palbociclib

DRUG

Fulvestrant

DRUG

Letrozole

Sponsors & Collaborators

  • MedSIR

    lead OTHER

Principal Investigators

  • Antonio Llombart, MD · MedSIR

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2020-01-31
Completion
2020-01-31

Countries

  • Czechia
  • France
  • Germany
  • Italy
  • Russia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02491983 on ClinicalTrials.gov