NCT05505175

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2023

Completed
Last Updated

May 25, 2023

Status Verified

May 1, 2023

Enrollment Period

11 months

First QC Date

August 15, 2022

Last Update Submit

May 24, 2023

Conditions

Breast CancerBreast Carcinoma

Keywords

non-metastatic breast cancerlocally advanced (stage III) breast cancermetastatic breast cancer (stage IV)

Outcome Measures

Primary Outcomes (13)

  • Demographical characteristics of patients who have received palbociclib combination treatments in line with locally approved indications

    30 days after the physician first prescribed palbociclib + partner therapy following the approval of the indication in Brazil . From when palbociclib + letrozole was available Feb 1, 2018 in Brazil and the physician initiated a patient on palbociclib+ letrozole until completion of this study in 2022.

    30 days after prescribed palbociclib + partner therapy until completion of this study in 2022.

  • Adjuvant treatments received for subset of patients previously diagnosed with non-metastatic breast cancer who progressed to locally advanced (stage IIIB/C) or metastatic (stage IV) breast cancer.

    30 days after the physician first prescribed palbociclib + partner therapy following the approval of the indication in Brazil . From when palbociclib + letrozole was available Feb 1, 2018 in Brazil and the physician initiated a patient on palbociclib+ letrozole until completion of this study in 2022.

    30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.

  • Describe treatments received in the advanced/metastatic setting before palbociclib combination use

    30 days after the physician first prescribed palbociclib + partner therapy following the approval of the indication in Brazil . From when palbociclib + letrozole was available Feb 1, 2018 in Brazil and the physician initiated a patient on palbociclib+ letrozole until completion of this study in 2022.

    30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.

  • Describe treatments received in the advanced/metastatic setting after palbociclib combination use

    30 days after the physician first prescribed palbociclib + partner therapy following the approval of the indication in Brazil . From when palbociclib + letrozole was available Feb 1, 2018 in Brazil and the physician initiated a patient on palbociclib+ letrozole until completion of this study in 2022.

    30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.

  • Describe dosing associated with palbociclib use in clinical practice

    30 days after the physician first prescribed palbociclib + partner therapy following the approval of the indication in Brazil . From when palbociclib + letrozole was available Feb 1, 2018 in Brazil and the physician initiated a patient on palbociclib+ letrozole until completion of this study in 2022.

    30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.

  • Describe dose changes associated with palbociclib use in clinical practice

    30 days after the physician first prescribed palbociclib + partner therapy following the approval of the indication in Brazil . From when palbociclib + letrozole was available Feb 1, 2018 in Brazil and the physician initiated a patient on palbociclib+ letrozole until completion of this study in 2022.

    30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.

  • Describe interruptions associated with palbociclib use in clinical practice

    30 days after the physician first prescribed palbociclib + partner therapy following the approval of the indication in Brazil . From when palbociclib + letrozole was available Feb 1, 2018 in Brazil and the physician initiated a patient on palbociclib+ letrozole until completion of this study in 2022.

    30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.

  • Describe delays associated with palbociclib use in clinical practice

    30 days after the physician first prescribed palbociclib + partner therapy following the approval of the indication in Brazil . From when palbociclib + letrozole was available Feb 1, 2018 in Brazil and the physician initiated a patient on palbociclib+ letrozole until completion of this study in 2022.

    30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.

  • Describe discontinuations associated with palbociclib use in clinical practice

    30 days after the physician first prescribed palbociclib + partner therapy following the approval of the indication in Brazil . From when palbociclib + letrozole was available Feb 1, 2018 in Brazil and the physician initiated a patient on palbociclib+ letrozole until completion of this study in 2022.

    30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.

  • Describe supportive therapies received by patients while receiving palbociclib combination treatments

    30 days after the physician first prescribed palbociclib + partner therapy following the approval of the indication in Brazil . From when palbociclib + letrozole was available Feb 1, 2018 in Brazil and the physician initiated a patient on palbociclib+ letrozole until completion of this study in 2022.

    30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.

  • Proportion of patients who are progression free following clinical outcomes in overall population and defined subgroups for patients who had a potential follow-up of 6 months after palbociclib combination treatment initiation

    30 days after the physician first prescribed palbociclib + partner therapy following the approval of the indication in Brazil . From when palbociclib + letrozole was available Feb 1, 2018 in Brazil and the physician initiated a patient on palbociclib+ letrozole until completion of this study in 2022.

    30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.

  • Real world Objective response rate (ORR) following clinical outcomes in overall population and defined subgroups for patients who had a potential follow-up of 6 months after palbociclib combination treatment initiation

    30 days after the physician first prescribed palbociclib + partner therapy following the approval of the indication in Brazil . From when palbociclib + letrozole was available Feb 1, 2018 in Brazil and the physician initiated a patient on palbociclib+ letrozole until completion of this study in 2022.

    30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.

  • Proportion of patients alive following clinical outcomes in overall population and defined subgroups for patients who had a potential follow-up of 6 months after palbociclib combination treatment initiation

    30 days after the physician first prescribed palbociclib + partner therapy following the approval of the indication in Brazil . From when palbociclib + letrozole was available Feb 1, 2018 in Brazil and the physician initiated a patient on palbociclib+ letrozole until completion of this study in 2022.

    30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.

Study Arms (1)

Breast Cancer Patients

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

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale participants only
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult female patients with HR+/HER2 non-metastatic breast cancer who progressed to locally advanced (stage IIIB/C) or metastatic (stage IV) breast cancer receiving palbociclib combination regimens as per the approved indication.

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

NOB - Nucleo de Oncologia da Bahia

Salvador, Estado de Bahia, 40170-110, Brazil

Location

Ensino E Terapia de Inovação Clínica Amo - Ética

Salvador, Estado de Bahia, 41.830-492, Brazil

Location

Instituto D´Or de Pesquisa E Ensino - Brasília

Brasília, Federal District, 70.390-700, Brazil

Location

Hospital Sírio Libanês

Brasília, Federal District, 70200-730, Brazil

Location

Hospital Araújo Jorge

Goiânia, Goiás, 74605-070, Brazil

Location

Oncoclínicas Do Brasil Servicos Médicos S/A - Oncocentro

Belo Horizonte, Minas Gerais, 30.360-680, Brazil

Location

Centro Especializado de Oncologia de Florianópolis

Florianópolis, 88032-005, Brazil

Location

Instituto de Mastologia e Oncologia

Goiânia, 74110-060, Brazil

Location

Instituto D'or de Pesquisa e Ensino

Recife, 50070-480, Brazil

Location

Centro de Tratamento de Tumores Botafogo

Rio de Janeiro, 22.250-905, Brazil

Location

Instituto D´or de Pesquisa e Ensino

Rio de Janeiro, 22281-100, Brazil

Location

Instituto de Educação, Pesquisa e Gestão em Saúde

Rio de Janeiro, 22793-080, Brazil

Location

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

São Paulo, 01323-000, Brazil

Location

Hcor - Associação Beneficente Síria

São Paulo, 04004-030, Brazil

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2022

First Posted

August 17, 2022

Study Start

May 30, 2022

Primary Completion

May 2, 2023

Study Completion

May 2, 2023

Last Updated

May 25, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Locations

BR(14)