Observational Analysis of Palbociclib Treatment in Patients With First Line Therapy for Locally Advanced and/or Metastatic Breast Cancer (PALBOSPAIN)

August 4, 2022 updated by: Fernando Moreno Antón, Hospital San Carlos, Madrid

Observational Analysis of Treatment With Palbociclib in Patients With Locally Advanced and / or Metastatic RH + / HER 2- Breast Cancer in the First Line of Treatment Within Routine Clinical Practice.

Hormone therapy is the primary treatment option for patients with HR+ HER2- breast cancer. Despite its activity, hormone therapy is associated with initial, or more frequently acquired, resistance after exposure to one or more treatment lines.

The combination of palbociclib with hormone therapy significantly increases progression free survival (PFS) compared with hormone therapy in first and second treatment line of HR+ HER2- advanced breast cancer.

These results lead to palbociclib approval by the Food and Drug Administration (FDA) in February 2015, and European Medicines Agency (EMA) approval in November 2016 for first-line treatment of patients with metastatic HR+/HER2-breast cancer in combination with an aromatase inhibitor, and for patients who had previously received hormone therapy in combination with fulvestrant.

In Spain, palbociclib was launched last November 1st, 2017. During this period, approximately 3500 patients have received treatment with Palbociclib, and approximately a half of them in first-line treatment in combination with hormone therapy. The collection of efficacy and toxicity data in the first-line usage in the clinical practice setting is of clinical interest.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

815

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28034
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28006
        • Hospital Universitario de La Princesa
      • Madrid, Spain, 28009
        • Hospital Universitario Gregorio Maranon
      • Murcia, Spain, 30008
        • Hospital General Universitario Morales Meseguer
      • Valencia, Spain, 46015
        • Arnau Vilanova Valencia
    • Andalucía
      • Córdoba, Andalucía, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Granada, Andalucía, Spain, 18014
        • Hospital Universitario Virgen de las Nieves
      • Sevilla, Andalucía, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Sevilla, Andalucía, Spain, 41013
        • Hospital Univesitario Virgen del Rocío
    • Aragón
      • Zaragoza, Aragón, Spain, 50009
        • Hospital Clínico Universitario Lozano Blesa
      • Zaragoza, Aragón, Spain, 50009
        • Hospital Universitario Miguel Servet
    • Asturias
      • Gijón, Asturias, Spain, 33394
        • Hospital Universitario de Cabueñes
      • Oviedo, Asturias, Spain, 33011
        • Hospital Central de Asturias
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
    • Castilla Y La Mancha
      • Guadalajara, Castilla Y La Mancha, Spain, 190002
        • Hospital Universitario de Guadalajara
      • Toledo, Castilla Y La Mancha, Spain, 45004
        • Hospital Virgen de la Salud
    • Castilla Y León
      • Burgos, Castilla Y León, Spain, 09006
        • Hospital Universitario de Burgos
      • León, Castilla Y León, Spain, 24071
        • Hospital Universitario de Leon
    • Cataluña
      • Barcelona, Cataluña, Spain, 08003
        • Hospital del Mar
      • Barcelona, Cataluña, Spain, 08041
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Cataluña, Spain, 08035
        • Hospital Universitario Vall D´Hebron
      • L'Hospitalet De Llobregat, Cataluña, Spain, 08908
        • ICO Hospitalet
      • Lleida, Cataluña, Spain, 25198
        • Arnau Vilanova Lleida
    • Comunidad Valenciana
      • Elche, Comunidad Valenciana, Spain, 03203
        • Hospital General Universitario de Elche
    • Extremadura
      • Cáceres, Extremadura, Spain, 10004
        • Hospital Universitario de Cáceres
    • Galicia
      • A Coruña, Galicia, Spain, 15006
        • Hospital Universitario de La Coruña
      • Ferrol, Galicia, Spain, 15405
        • Hospital Universitario de Ferrol
      • Santiago De Compostela, Galicia, Spain, 15706
        • Hospital Cínico Universitario de Santiago de Compostela
    • Islas Baleares
      • Palma De Mallorca, Islas Baleares, Spain, 07120
        • Hospital Son Espases
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universitaria De Navarra
      • Pamplona, Navarra, Spain, 31008
        • Complejo Hospitalario de Navarra
    • Pais Vasco
      • Bilbao, Pais Vasco, Spain, 48013
        • Hospital Universitario de Basurto
      • Donostia, Pais Vasco, Spain, 20014
        • Hospital Universitario Donostia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with advanced or metastatic breast cancer receiving palbociclib in first line in 35 Hospitals from Spain.

Description

Inclusion Criteria:

  • 1. Documented histologically confirmed breast cancer with ER and/or PgR positive and HER2 negative status.
  • 2. Locally advanced or metastatic breast cancer not deemed amenable to curative surgery or curative radiation therapy

  • 3. HR+/HER2-

    1. HR+: ER+ or PR+ test before or up to 60 days after MBC diagnosis
    2. HER2-: any HER2 negative test and the absence of a positive test (IHC positive 3+, FISH positive/amplified, Positive NOS) before or up to 60 days after MBC diagnosis
  • 4. Female or male patients > 18 years
  • 5. Have received at least one dose of palbociclib
  • 6. At least 2 document clinical visits
  • 7. Treatment with palbociclib should have started from November 2017 to November 2019
  • 8. Data from the clinical records should be available.
  • 9. Patients must be able to understand and sign informed consent if alive.

Exclusion Criteria:

  • 1. Previous treatment with hormonal therapy, targeted therapy or chemotherapy for metastatic disease. Previous anticancer treatment for early breast cancer are allowed.
  • 2. Treatment with palbociclib in clinical trial or compassionate use programs
  • 3. HER2 + (IHC 3+ or FISH +) tumors in the most recent or previous biopsies
  • 4. HR negative tumors in the most recent biopsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Real-world progression free survival (rwPFS)
Time Frame: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 52 months
Median time (months) from index date to death, disease progression based on radiology, laboratory evidence, pathology, or clinical assessment until next line therapy, or end of the study, whichever came first, assessed up to 52 months
From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 52 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Real-world tumor response (rwTR)
Time Frame: From date of index treatment to date of disease progression, date of death, or end of study whichever came first, assessed up to 52 months
Real-world tumor response is defined as complete response or partial response, based on treating clinician's assessment of radiological evidence for change in burden of disease over the course of treatment
From date of index treatment to date of disease progression, date of death, or end of study whichever came first, assessed up to 52 months
Time to next line of therapy
Time Frame: From date of index treatment to date of next line therapy, date of death, or end of study, whichever came first, assessed up to 52 months
Median time (months) from date of index treatment to date of next line therapy, date of death, or end of study, whichever came first, assessed up to 52 months
From date of index treatment to date of next line therapy, date of death, or end of study, whichever came first, assessed up to 52 months
Overall Survival
Time Frame: Time Frame: From date of index treatment until date of death from any accuse or date of end of study, whichever came first, assessed up to 52 months
Median time (months) from date of index treatment to date of death. Patients who did not die in the study period are censored at their last date in the study.
Time Frame: From date of index treatment until date of death from any accuse or date of end of study, whichever came first, assessed up to 52 months
Time to first use of chemotherapy
Time Frame: From date of index treatment to date of first use of chemotherapy, date of death, or end of study, whichever came first, assessed up to 52 months
Median time (months) from date of index treatment to date of first use of chemotherapy, date of death, or end of study, whichever came first, assessed up to 52 months
From date of index treatment to date of first use of chemotherapy, date of death, or end of study, whichever came first, assessed up to 52 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital San Carlos, Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2021

Primary Completion (Actual)

June 8, 2022

Study Completion (Actual)

June 8, 2022

Study Registration Dates

First Submitted

April 30, 2021

First Submitted That Met QC Criteria

April 30, 2021

First Posted (Actual)

May 5, 2021

Study Record Updates

Last Update Posted (Actual)

August 8, 2022

Last Update Submitted That Met QC Criteria

August 4, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PALBOSPAIN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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