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

Breast Cancer Clinical Trial

— PALBOSPAIN  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04874025
• Other study ID #: PALBOSPAIN
• Status: Completed
• Start date: July 31, 2021
• Est. completion date: June 8, 2022

Study information

• Verified date: August 2022
• Source: Hospital San Carlos, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 815
• Est. completion date: June 8, 2022
• Est. primary completion date: June 8, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Ibrance
Observational study of Ibrance 75 mg, 100 mg and 125 mg.

Locations

Country	Name	City	State
Spain	Hospital Universitario de La Coruña	A Coruña	Galicia
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Cataluña
Spain	Hospital del Mar	Barcelona	Cataluña
Spain	Hospital Universitario Vall d´Hebrón	Barcelona	Cataluña
Spain	Hospital Universitario de Basurto	Bilbao	Pais Vasco
Spain	Hospital Universitario de Burgos	Burgos	Castilla Y León
Spain	Hospital Universitario de Cáceres	Cáceres	Extremadura
Spain	Hospital Universitario Reina Sofía	Córdoba	Andalucía
Spain	Hospital Universitario Donostia	Donostia	Pais Vasco
Spain	Hospital General Universitario de Elche	Elche	Comunidad Valenciana
Spain	Hospital Universitario de Ferrol	Ferrol	Galicia
Spain	Hospital Universitario de Cabueñes	Gijón	Asturias
Spain	Hospital Universitario Virgen de las Nieves	Granada	Andalucía
Spain	Hospital Universitario de Guadalajara	Guadalajara	Castilla Y La Mancha
Spain	ICO Hospitalet	L'Hospitalet De Llobregat	Cataluña
Spain	Hospital Universitario de León	León	Castilla Y León
Spain	Arnau Vilanova Lleida	Lleida	Cataluña
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario de la Princesa	Madrid
Spain	Hospital Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital General Universitario Morales Meseguer	Murcia
Spain	Hospital Central de Asturias	Oviedo	Asturias
Spain	Hospital Son Espases	Palma De Mallorca	Islas Baleares
Spain	Clínica Universitaria de Navarra	Pamplona	Navarra
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Hospital Cínico Universitario de Santiago de Compostela	Santiago De Compostela	Galicia
Spain	Hospital Universitario Virgen Macarena	Sevilla	Andalucía
Spain	Hospital Univesitario Virgen del Rocío	Sevilla	Andalucía
Spain	Hospital Virgen de la Salud	Toledo	Castilla Y La Mancha
Spain	Arnau Vilanova Valencia	Valencia
Spain	Hospital Clínico Universitario Lozano Blesa	Zaragoza	Aragón
Spain	Hospital Universitario Miguel Servet	Zaragoza	Aragón

Sponsors (1)

Lead Sponsor	Collaborator
Hospital San Carlos, Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	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
Secondary	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	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
Secondary	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	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
Secondary	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	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