Outcomes Among Patients in Brazil Receiving Palbociclib Combinations for HR+/HER2- MBC

NCT ID: NCT05505175

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-30
• Study Completion Date: 2023-05-02

Brief Summary

The objective of this study is 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 Brazil.

Detailed Description

The primary objective of this real world study is 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.

Primary Objectives

• To describe the demographic and clinical characteristics of patients who have received palbociclib combination treatments in line with locally approved indications.
• To describe adjuvant therapies received for their treatment of early or locally advanced breast cancer (Stages 0-IIIa).
• To describe treatments received in the advanced/metastatic setting, before and after palbociclib combination use.
• To describe dosing and dose changes, interruptions, delays, and discontinuations associated with palbociclib use in clinical practice.
• To describe supportive therapies received by patients while receiving palbociclib combination treatments.
• To determine the following outcome in overall population and defined subgroups for patients who had received palbociclib combination treatment for at least 6 months:

• Progression-free survival;
• Objective response rate (ORR);
• Proportion of patients alive.

Exploratory Objectives

• To evaluate progression-free survival (PFS) associated with palbociclib combination treatments after 1 and 2 years following Palbociclib combination treatment.

This study will be conducted as a retrospective medical record review of patients who have received palbociclib combination treatments as first line treatment regardless of combination. The study will comprise of a medical record review conducted in Brazil. The study design is similar to a previously conducted RWE IRIS Global study previously conducted in multiple other countries (protocol no. A5481090) .

Data collection will be online via electronic data capture using electronic case report form (eCRF). Each physician will be asked to select all the medical records of approximately 5-20 patients per site (approximate total: 300 patients) who meet the inclusion criteria and then invited to complete the eCRF from each enrolled patient. Time to complete each eCRF will be 30 minutes, approximately.

In order to allow for a sufficiently long observational window, physicians will be asked to go back to a specific point in time, the index date, and sequentially select the medical records of the next 'n' patients who meet the inclusion criteria. The 'index date' will be defined as 30 days after the physician first prescribed palbociclib + partner therapy following the approval of the indication in Brazil (eg, if palbociclib + letrozole was available Feb 1, 2018 in Brazil and the physician initiated a patient on palbociclib+ letrozole the next day, the index date will be April 2, 2018).

The advantage to a retrospective medical record review approach over a database analysis is that of being designed specifically to collect data that fulfils the study objectives. Thus, it readily collects and informs on all key drug related clinical outcome measures of critical importance to this study, in a consistent manner, across countries if reported in a medical record. The resulting data set enables direct comparisons across markets, delivering in turn greater confidence in the reliability of conclusions drawn from the research. An additional advantage of this approach lies in the ability to obtain information that only the treating physician may be aware of, such as the reasons for treatment switches or discontinuations or more perceptive questions that rely on the physician's professional opinion.

Conditions

Breast Cancer; Breast Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Breast Cancer Patients

Eligible patients including patients with a potential follow-up period of 6 months following the index date

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• HR+/HER2- breast cancer diagnosis with confirmed ABC/MBC
• Received palbociclib as a first line therapy
• No prior or current enrolment in an interventional clinical trial for ABC/MBC
• Have a potential follow-up period of 6 months following the index date (30 days after first palbociclib prescription: palbociclib with fulvestrant and/or palbociclib with letrozole/aromatase inhibitor).

Exclusion Criteria

• Patients who were enrolled to receive fulvestrant but already received previous therapies

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

NOB - Nucleo de Oncologia da Bahia

Salvador, Estado de Bahia, Brazil

Ensino E Terapia de Inovação Clínica Amo - Ética

Salvador, Estado de Bahia, Brazil

Instituto D´Or de Pesquisa E Ensino - Brasília

Brasília, Federal District, Brazil

Hospital Sírio Libanês

Brasília, Federal District, Brazil

Hospital Araújo Jorge

Goiânia, Goiás, Brazil

Oncoclínicas Do Brasil Servicos Médicos S/A - Oncocentro

Belo Horizonte, Minas Gerais, Brazil

Centro Especializado de Oncologia de Florianópolis

Florianópolis, , Brazil

Instituto de Mastologia e Oncologia

Goiânia, , Brazil

Instituto D'or de Pesquisa e Ensino

Recife, , Brazil

Centro de Tratamento de Tumores Botafogo

Rio de Janeiro, , Brazil

Instituto D´or de Pesquisa e Ensino

Rio de Janeiro, , Brazil

Instituto de Educação, Pesquisa e Gestão em Saúde

Rio de Janeiro, , Brazil

Hospital Paulistano - INSTITUTO DE EDUCAÇÃO, PESQUISA E GESTÃO EM SAÚDE

São Paulo, , Brazil

Hcor - Associação Beneficente Síria

São Paulo, , Brazil

Countries

Brazil

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=A5481168

To obtain contact information for a study center near you, click here.

Other Identifiers

IRIS Brazil

Identifier Type: OTHER

Identifier Source: secondary_id

A5481168

Identifier Type: -

Identifier Source: org_study_id