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

Hospital San Carlos, Madrid815 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

815

Conditions

Breast Cancer

Interventions

Ibrance

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (36)

Hospital Universitario Reina Sofía

Córdoba, Andalusia, Spain

Hospital Universitario Virgen de las Nieves

Granada, Andalusia, Spain

Hospital Universitario Virgen Macarena

Seville, Andalusia, Spain

Hospital Univesitario Virgen del Rocío

Seville, Andalusia, Spain

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Aragon, Spain

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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: 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)

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 frame: 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

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

Time frame: 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

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 frame: 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