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

NCT04874025 | Completed

• 1 other identifier: PALBOSPAIN
• Study Type: observational
• Target: 815
• Locations: 1 country
• Sites: 36

Brief 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. 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.

Conditions

Breast Cancer

Keywords

Breast Cancer.; Real-world data.; Palbociclib

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (4)

• Overall Survival

  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

• Real-world tumor response (rwTR)

  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

  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

• Time to first use of chemotherapy

  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

Interventions

Ibrance DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \. Documented histologically confirmed breast cancer with ER and/or PgR positive and HER2 negative status.
• \. Locally advanced or metastatic breast cancer not deemed amenable to curative surgery or curative radiation therapy
• \. 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
• \. Female or male patients \> 18 years
• \. Have received at least one dose of palbociclib
• \. At least 2 document clinical visits
• \. Treatment with palbociclib should have started from November 2017 to November 2019
• \. Data from the clinical records should be available.
• \. Patients must be able to understand and sign informed consent if alive.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead

Study Sites (36)

Hospital Universitario Reina Sofía

Córdoba, Andalusia, 14004, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, Andalusia, 18014, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Andalusia, 41009, Spain

Location

Hospital Univesitario Virgen del Rocío

Seville, Andalusia, 41013, Spain

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Aragon, 50009, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Aragon, 50009, Spain

Location

Hospital Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

Hospital Universitario de Basurto

Bilbao, Basque Country, 48013, Spain

Location

Hospital Universitario Donostia

Donostia / San Sebastian, Basque Country, 20014, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Universitario de Guadalajara

Guadalajara, Castilla Y La Mancha, 190002, Spain

Location

Hospital Virgen de la Salud

Toledo, Castilla Y La Mancha, 45004, Spain

Location

Hospital Universitario de Burgos

Burgos, Castille and León, 09006, Spain

Location

Hospital Universitario de León

León, Castille and León, 24071, Spain

Location

Hospital del Mar

Barcelona, Catalonia, 08003, Spain

Location

Hospital Universitario Vall d´Hebrón

Barcelona, Catalonia, 08035, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08041, Spain

Location

ICO Hospitalet

L'Hospitalet de Llobregat, Catalonia, 08908, Spain

Location

Arnau Vilanova Lleida

Lleida, Catalonia, 25198, Spain

Location

Hospital Universitario de Cáceres

Cáceres, Extremadura, 10004, Spain

Location

Hospital Universitario de La Coruña

A Coruña, Galicia, 15006, Spain

Location

Hospital Universitario de Ferrol

Ferrol, Galicia, 15405, Spain

Location

Hospital Cínico Universitario de Santiago de Compostela

Santiago de Compostela, Galicia, 15706, Spain

Location

Clínica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario de Cabueñes

Gijón, Principality of Asturias, 33394, Spain

Location

Hospital Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital General Universitario de Elche

Elche, Valencia, 03203, Spain

Location

Hospital Universitario de la Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Gregorio Marañón

Madrid, 28009, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital General Universitario Morales Meseguer

Murcia, 30008, Spain

Location

Arnau Vilanova Valencia

Valencia, 46015, Spain

Location

Related Publications (1)

• 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.

  PMID: 38561577 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 5, 2021
• Study Start: July 31, 2021
• Primary Completion: June 8, 2022
• Study Completion: June 8, 2022
• Last Updated: August 8, 2022

Record last verified: 2022-08

Locations

ES (36)