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To Reverse ENDocrine Resistance Trial - PD 0332991 Monotherapy vs PD 0332991 in Combination With the Endocrine Therapy

NCT02549430 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2017-08-01

No results posted yet for this study

Summary

This study aims to assess the activity of PD0332991 in monotherapy and in combination with the endocrine therapy (anastrozole, letrozole, exemestane or fulvestrant) on which the patient has progressed in the previous line for advanced breast cancer in order to reverse endocrine resistance.

Conditions

Interventions

DRUG

Palbociclib

Palbociclib 125 mg/day orally in an ongoing 3:1 schedule (3 weeks on/1 week off)

DRUG

Anastrozole

Continuation of prior anastrozole 1mg/day orally in a continuous regimen

DRUG

Letrozole

Continuation of prior letrozole 2.5mg/day orally in a continuous regimen

DRUG

Exemestane

Continuation of prior exemestane 25mg/day orally in a continuous regimen

DRUG

Fulvestrant

Continuation of prior fulvestrant 500mg intramuscular injection every 4 weeks in a continuous regimen

Sponsors & Collaborators

  • Fondazione Sandro Pitigliani

    lead OTHER

Principal Investigators

  • LUCA MALORNI, MD · Azienda USL 4 Prato

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2017-02-09
Completion
2017-02-09

Countries

  • Italy

Study Locations

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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 NCT02549430 on ClinicalTrials.gov