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Analysis of Palbociclib Treatment in Patients With Advanced Breast Cancer Within a Compassionate Use Programe

NCT04109261 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 237

Last updated 2019-09-30

No results posted yet for this study

Summary

In Spain, palbociclib was launched last November 1st, 2017. However, since February 2015 the on-going compassionate use programme of palbociclib has enabled drug access to patients with RH+/HER2- breast cancer previously treated with at least 4 treatment lines for advanced disease. During this period, approximately 400 patients have received treatment within this programme. Since this population of patients more pre-treated was not included in the studies for regulatory submission, the collection of efficacy and toxicity data in the clinical practice setting is of clinical interest.

Conditions

Interventions

DRUG

Palbociclib

Palbociclib administration in breast cancer patients included in a compassionate use programme. Patients were treated according to the standard of care

Sponsors & Collaborators

  • Fernando Moreno Antón

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-18
Primary Completion
2019-09-01
Completion
2019-09-01

Countries

  • 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 NCT04109261 on ClinicalTrials.gov