An observational study in Breast Cancer and Breast Carcinoma, sponsored by Pfizer. Completed at 14 sites in Brazil. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by Pfizer · Observational
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.
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 determine the following outcome in overall population and defined subgroups for patients who had received palbociclib combination treatment for at least 6 months:
Exploratory Objectives
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 121 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
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Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Eligible patients including patients with a potential follow-up period of 6 months following the index date
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.
Plan to share: No — 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.
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