Clinical Trials/NCT02491983

NCT02491983

Completed

Phase 2

A Randomized, Multicenter, Open-label, Phase II Trial to Evaluate the Efficacy and Safety of Palbociclib in Combination With Fulvestrant or Letrozole in Patients With HER2 Negative, ER+ Metastatic Breast Cancer

MedSIR2 sites in 2 countries486 target enrollmentAugust 2015

ConditionsMetastatic Breast Cancer

InterventionsPalbociclib Letrozole Fulvestrant

DrugsPalbociclib Fulvestrant Letrozole

Overview

Phase: Phase 2
Intervention: Palbociclib
Conditions: Metastatic Breast Cancer
Sponsor: MedSIR
Enrollment: 486
Locations: 2
Primary Endpoint: 1-year Progression Free Survival
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

Patients will be stratified by site of disease (visceral vs. non-visceral) and by onset of metastatic disease diagnose (patients metastatic de novo versus non de novo).

Registry

clinicaltrials.gov

Start Date

August 2015

End Date

January 2020

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

MedSIR

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Women 18 years or older with metastatic or locally advanced disease, not amenable to curative therapy
•Confirmed diagnosis of HR+/HER2- breast cancer
•Post-menopausal status
•No prior chemotherapy line in the metastatic setting
•Measurable disease defined by RECIST version 1.1, or non-measurable disease
•Eastern Cooperative Oncology Group (ECOG) PS 0-1
•Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures
•Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCICTCAE version 4.0 Grade equal or minor than 1

Exclusion Criteria

•ER or HER2 unknown disease
•HER2 positive disease based on local laboratory results
•Locally advanced breast cancer candidate for a radical treatment
•Prior (neo)adjuvant endocrine treatment with DFI ≤ 12-months from completion of treatment.
•Patients with rapidly progressive visceral disease or visceral crisis.
•Major surgery within 4 weeks of start of study drug
•Patients with an active, bleeding diathesis
•Serious concomitant systemic disorder incompatible with the study
•Are unable to swallow tablets
•Chronic daily treatment with corticosteroids with a dose of ≥ 10mg/day methylprednisolone equivalent

Arms & Interventions

Arm A

Combination of Palbociclib and Letrozole

Intervention: Palbociclib

Arm A

Combination of Palbociclib and Letrozole

Intervention: Letrozole

Arm B

Combination of Palbociclib and Fulvestrant

Intervention: Palbociclib

Arm B

Combination of Palbociclib and Fulvestrant

Intervention: Fulvestrant

Outcomes

Primary Outcomes

1-year Progression Free Survival

Time Frame: One year

Percentage of patients who are alive and without evidence of tumor progression (defined using RECIST v1.1)

Secondary Outcomes

Number of Participants With Grade 3/4 Adverse Events, SAEs, Deaths and Discontinuations •(Through study completion. From baseline up to 51 months.)
Time To Progression (TTP)(Through study completion. From baseline up to 51 months.)
Overall Survival (OS)(Through study completion. From baseline up to 51 months.)
Clinical Benefit Rate(Through study completion. From baseline up to 51 months.)
Overall Response Rate(Through study completion. From baseline up to 51 months.)