Treatment Patterns And Clinical Outcomes Among Patients in Latin America Receiving First Line Palbociclib Combinations For HR+/HER2- Advanced/Metastatic Breast Cancer In Real World Settings.

Study Overview
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Brief Summary
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To describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments as first line therapy, regardless of combination partner and labelled use in real world settings across Latin America.

Official Title
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Treatment Patterns And Clinical Outcomes Among Patients in Latin America Receiving First Line Palbociclib Combinations For HORMONE RECEPTOR POSITIVE/ HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE (HR+/HER2-) Advanced/Metastatic Breast Cancer In Real World Settings

Conditions
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Breast Cancer Metastatic

Participation Criteria
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Eligibility Criteria
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Physician inclusion criteria: Oncologist or gynecologist. Responsible for treating ≥4-10 (depending on country) ABC/MBC patients who meet the eligibility criteria. Agrees to participate in the study and complete the case report forms (CRFs) within the data collection period. Patient inclusion criteria: HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease. Received palbociclib as a first line therapy. No prior or current enrolment in an interventional clinical trial for ABC/MBC. Minimum of six months of follow up data since palbociclib initiation. Physician exclusion criteria: Qualified less than 2 years ago or more than 35 years ago. Participated in observational research for ABC/MBC in the last 3 months. Have not prescribed either palbociclib plus fulvestrant or palbociclib plus aromatase inhibitor as first line therapy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast Cancer Patients<br>HR + /HER2- Advanced/Metastatic Breast Cancer patients in Latin America | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of patients demographics receiving Palbociclib |  | Day 1 of treatment to date of latest follow up | 
| Clinical characteristics of patients receiving Palbociclib |  | Day 1 of treatment to date of latest follow up | 
| Adjuvant therapies received for the treatment of early or locally advanced breast cancer (Stages 0-IIIa) |  | From the initial diagnosis to the metastatic disease (From data collected retrospectively for 18 months) | 
| To describe treatments received in the advanced/ metastatic setting, before and after palbociclib combination use. |  | From the initial diagnosis in the metastatic disease (From data collected retrospectively for 18 months) | 
| Percentage of Participants With Reduced Doses of Palbociclib | Colombia was the last country starting July 2020 and finalized October 2020 | June 2019 to September 2019 | 
| Percentage of Participants With Dose interruption of Palbociclib | Colombia was the last country starting July 2020 and finalized October 2020 | June 2019 to September 2019 | 
| Percentage of Participants With discontinuation of Palbociclib | Colombia was the last country starting July 2020 and finalized October 2020 | June 2019 to September 2019 | 
| Percentage of Participants With Delay Doses of Palbociclib | Colombia was the last country starting July 2020 and finalized October 2020 | June 2019 to September 2019 | 
| Supportive therapies received by patients while receiving palbociclib combination treatments | Colombia was the last country starting July 2020 and finalized October 2020 | June 2019 to September 2019 | 
| Proportion of patients who are progression free at multiple intervals (e.g.12, 18 months) | Colombia was the last country starting July 2020 and finalized October 2020 | June 2019 to September 2019 | 
| Proportion of patients with Objective response rate (ORR) | Colombia was the last country starting July 2020 and finalized October 2020 | June 2019 to September 2019 | 
| Overall survival rate |  | Proportion of patients alive 1- and 2-year post palbociclib combination initiation - depending on availability of follow-up data | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic breast cancer (MBC), human epidermal growth factor receptor 2 negative (HER2-), hormone receptor positive (HR+), advanced breast cancer (ABC)