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Molecular Mechanisms of Resistance and Sensitivity to Palbociclib Re-challenge in ER+ mBC

NCT03184090 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2022-06-21

No results posted yet for this study

Summary

This is an international, open-label, non-controlled, multicenter phase II clinical trial with two different primary objectives: a biological and a clinical objective.

From a clinical point of view, the objective is to assess the clinical benefit of the combination of palbociclib and hormonotherapy in patients with advance breast cancer that had previously received endocrine therapy in combination with palbociclib and had achieved clinical benefit during palbociclib treatment with subsequent disease progression.

From a biological point of view, the challenge is to define a molecular profile that allow identifying patients that could benefit more from continuing on palbociclib after progression on a prior palbociclib-containing regimen

Conditions

Interventions

DRUG

Palbociclib

palbociclib in combination with endocrine therapy (investigator's choice)

DRUG

Endocrine therapy (non IMP)

Endocrine therapy (physician's choice based on prior administered agent including tamoxifen, exemestane, fulvestrant, anastrozole, or letrozole). Endocrine therapy must be different from previous treatment line.

Sponsors & Collaborators

  • MedSIR

    lead OTHER

Principal Investigators

  • Javier Cortes, MD PhD · Hospital Universitario Ramon y Cajal

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-28
Primary Completion
2020-10-27
Completion
2020-10-27

Countries

  • Italy
  • Spain

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 NCT03184090 on ClinicalTrials.gov