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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT04874025
• Lead Sponsor: Hospital San Carlos, Madrid

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-30
• Study First Submitted QC: 2021-04-30
• Study First Posted: 2021-05-05
• Study Start: 2021-07-31
• Primary Completion: 2022-06-08
• Study Completion: 2022-06-08
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-04
• Last Update Posted: 2022-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 815

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-

  4. HR+: ER+ or PR+ test before or up to 60 days after MBC diagnosis

  5. 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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Real-world progression free survival (rwPFS)	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

Secondary Outcome Measures

Name	Time	Method
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	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.
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	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
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	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
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	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

Trial Locations

Locations (36)

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Andalucía, Spain

Hospital Univesitario Virgen del Rocío; 🇪🇸 Sevilla, Andalucía, Spain

Hospital Universitario Reina Sofía; 🇪🇸 Córdoba, Andalucía, Spain

Hospital del Mar; 🇪🇸 Barcelona, Cataluña, Spain

Clínica Universitaria de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Andalucía, Spain

Hospital Universitario Vall d´Hebrón; 🇪🇸 Barcelona, Cataluña, Spain

Hospital Universitario de La Coruña; 🇪🇸 A Coruña, Galicia, Spain

Hospital Universitario de Basurto; 🇪🇸 Bilbao, Pais Vasco, Spain

Hospital Cínico Universitario de Santiago de Compostela; 🇪🇸 Santiago De Compostela, Galicia, Spain

Hospital Son Espases; 🇪🇸 Palma De Mallorca, Islas Baleares, Spain

Hospital Universitario de Ferrol; 🇪🇸 Ferrol, Galicia, Spain

Hospital Universitario de la Princesa; 🇪🇸 Madrid, Spain

Hospital Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital Clínico Universitario Lozano Blesa; 🇪🇸 Zaragoza, Aragón, Spain

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Aragón, Spain

Hospital Universitario de Cabueñes; 🇪🇸 Gijón, Asturias, Spain

Hospital Virgen de la Salud; 🇪🇸 Toledo, Castilla Y La Mancha, Spain

Hospital Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain

Hospital Universitario de Burgos; 🇪🇸 Burgos, Castilla Y León, Spain

Arnau Vilanova Lleida; 🇪🇸 Lleida, Cataluña, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Cataluña, Spain

ICO Hospitalet; 🇪🇸 L'Hospitalet De Llobregat, Cataluña, Spain

Hospital General Universitario de Elche; 🇪🇸 Elche, Comunidad Valenciana, Spain

Complejo Hospitalario de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario de Guadalajara; 🇪🇸 Guadalajara, Castilla Y La Mancha, Spain

Hospital Universitario de León; 🇪🇸 León, Castilla Y León, Spain

Hospital Universitario Donostia; 🇪🇸 Donostia, Pais Vasco, Spain

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario de Cáceres; 🇪🇸 Cáceres, Extremadura, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Arnau Vilanova Valencia; 🇪🇸 Valencia, Spain

Hospital General Universitario Morales Meseguer; 🇪🇸 Murcia, Spain

Hospital Universitario Marqués de Valdecilla; 🇪🇸 Santander, Cantabria, Spain