Clinical trial NCT04874025: Observational Analysis of Palbociclib Treatment in Patients With First Line Therapy for Locally Advanced and/or Metastatic Breast Cancer
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast Cancer.
Real-world data.
Palbociclib
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 815
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced or metastatic breast cancer receiving palbociclib in first line in 35 Hospitals from Spain.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Real-world progression free survival (rwPFS)
timeFrame: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 52 months
Secondary outcomes:
measure: Overall Survival
timeFrame: 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
measure: Real-world tumor response (rwTR)
timeFrame: 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
measure: Time to next line of therapy
timeFrame: 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
measure: Time to first use of chemotherapy
timeFrame: 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
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
state: Andalucía
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
state: Andalucía
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
state: Andalucía
city: Sevilla
country: Spain
facility: Hospital Univesitario Virgen del Rocío
state: Andalucía
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
state: Aragón
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
state: Aragón
city: Gijón
country: Spain
facility: Hospital Universitario de Cabueñes
state: Asturias
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
state: Asturias
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Guadalajara
country: Spain
facility: Hospital Universitario de Guadalajara
state: Castilla Y La Mancha
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
state: Castilla Y La Mancha
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
state: Castilla Y León
city: León
country: Spain
facility: Hospital Universitario de León
state: Castilla Y León
city: Barcelona
country: Spain
facility: Hospital del Mar
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d´Hebrón
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Cataluña
city: L'Hospitalet De Llobregat
country: Spain
facility: ICO Hospitalet
state: Cataluña
city: Lleida
country: Spain
facility: Arnau Vilanova Lleida
state: Cataluña
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Comunidad Valenciana
city: Cáceres
country: Spain
facility: Hospital Universitario de Cáceres
state: Extremadura
city: A Coruña
country: Spain
facility: Hospital Universitario de La Coruña
state: Galicia
city: Ferrol
country: Spain
facility: Hospital Universitario de Ferrol
state: Galicia
city: Santiago De Compostela
country: Spain
facility: Hospital Cínico Universitario de Santiago de Compostela
state: Galicia
city: Palma De Mallorca
country: Spain
facility: Hospital Son Espases
state: Islas Baleares
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra
state: Navarra
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Bilbao
country: Spain
facility: Hospital Universitario de Basurto
state: Pais Vasco
city: Donostia
country: Spain
facility: Hospital Universitario Donostia
state: Pais Vasco
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Murcia
country: Spain
facility: Hospital General Universitario Morales Meseguer
city: Valencia
country: Spain
facility: Arnau Vilanova Valencia
Study officials:
References: