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Breast CancerPALBOSPAINNCT04874025

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

An observational study of Breast Cancer, run by Hospital San Carlos, Madrid at 36 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Ibrance
How many people
815 participants
Where
36 sitesSpain
Study dates
31 Jul 2021to 8 Jun 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • 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-
  • HR+: ER+ or PR+ test before or up to 60 days after MBC diagnosis
  • 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
Show all 11Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

Spain36 sites

  • Hospital Universitario de La Coruña

    A Coruña, Galicia, 15006

  • Hospital del Mar

    Barcelona, Catalonia, 08003

  • Hospital Universitario Vall d´Hebrón

    Barcelona, Catalonia, 08035

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08041

  • Hospital Universitario de Basurto

    Bilbao, Basque Country, 48013

  • Hospital Universitario de Burgos

    Burgos, Castille and León, 09006

  • Hospital Universitario de Cáceres

    Cáceres, Extremadura, 10004

  • Hospital Universitario Reina Sofía

    Córdoba, Andalusia, 14004

  • Hospital Universitario Donostia

    Donostia / San Sebastian, Basque Country, 20014

  • Hospital General Universitario de Elche

    Elche, Valencia, 03203

  • Hospital Universitario de Ferrol

    Ferrol, Galicia, 15405

  • Hospital Universitario de Cabueñes

    Gijón, Principality of Asturias, 33394

  • Hospital Universitario Virgen de las Nieves

    Granada, Andalusia, 18014

  • Hospital Universitario de Guadalajara

    Guadalajara, Castilla Y La Mancha, 190002

  • ICO Hospitalet

    L'Hospitalet de Llobregat, Catalonia, 08908

  • Hospital Universitario de León

    León, Castille and León, 24071

  • Arnau Vilanova Lleida

    Lleida, Catalonia, 25198

  • Hospital Universitario de la Princesa

    Madrid, 28006

  • Hospital Universitario Gregorio Marañón

    Madrid, 28009

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008

  • Hospital Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Hospital Son Espases

    Palma de Mallorca, Balearic Islands, 07120

  • Clínica Universitaria de Navarra

    Pamplona, Navarre, 31008

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Cínico Universitario de Santiago de Compostela

    Santiago de Compostela, Galicia, 15706

  • Hospital Universitario Virgen Macarena

    Seville, Andalusia, 41009

  • Hospital Univesitario Virgen del Rocío

    Seville, Andalusia, 41013

  • Hospital Virgen de la Salud

    Toledo, Castilla Y La Mancha, 45004

  • Arnau Vilanova Valencia

    Valencia, 46015

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, Aragon, 50009

  • Hospital Universitario Miguel Servet

    Zaragoza, Aragon, 50009

Other trials in Spain

About this study

Official title: 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.

Read more

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.

Conditions
Breast Cancer
Being tested
Ibrance
Keywords
Breast Cancer., Real-world data., Palbociclib
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IbranceDrug

    Observational study of Ibrance 75 mg, 100 mg and 125 mg.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Real-world progression free survival (rwPFS)

    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

    Measured: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 52 months

Secondary outcomes (4)

  1. Overall Survival

    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.

    Measured: 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

  2. Real-world tumor response (rwTR)

    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

    Measured: 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

  3. Time to next line of therapy

    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

    Measured: 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

  4. Time to first use of chemotherapy

    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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2021
  2. Study start31 Jul 2021
  3. Primary completion8 Jun 2022
  4. Study completion8 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
815 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04874025
Sponsor's protocol ID
PALBOSPAIN
Acronym
PALBOSPAIN
Status last verified
Aug 2022
First submitted
30 Apr 2021
Last updated
8 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Martinez-Janez N, Ezquerra MB, Manso Sanchez LM, Carrasco FH, Torres AA, Morales S, Ortega PT, Gil VLO, Sampedro T, Conejero RA, Calvo-Martinez L, Galve-Calvo E, Lopez R, de la Pena FA, Lopez-Tarruella S, de Araguiz BAHF, Ruiz LB, Cardenas TM, Chacon JI, Anton FM. First-line therapy with palbociclib in patients with advanced HR+/HER2- breast cancer: The real-life study PALBOSPAIN. Breast Cancer Res Treat. 2024 Jul;206(2):317-328. doi: 10.1007/s10549-024-07287-w. Epub 2024 Apr 1.

    PubMed 38561577

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by Hospital San Carlos, Madrid at 36 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04874025, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2022.

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