Breast CancerNCT05505175
Outcomes Among Patients in Brazil Receiving Palbociclib Combinations for HR+/HER2- MBC
An observational study of Breast Cancer and Breast Carcinoma, run by Pfizer at 14 sites in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Carcinoma
- How many people
- 121 participants
- Where
- 14 sitesBrazil
- Study dates
- 30 May 2022to 2 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- Patients who were enrolled to receive fulvestrant but already received previous therapies
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Brazil14 sites
Oncoclínicas Do Brasil Servicos Médicos S/A - Oncocentro
Belo Horizonte, Minas Gerais, 30.360-680
Instituto D´Or de Pesquisa E Ensino - Brasília
Brasília, Federal District, 70.390-700
Hospital Sírio Libanês
Brasília, Federal District, 70200-730
Centro Especializado de Oncologia de Florianópolis
Florianópolis, 88032-005
Hospital Araújo Jorge
Goiânia, Goiás, 74605-070
Instituto de Mastologia e Oncologia
Goiânia, 74110-060
Instituto D'or de Pesquisa e Ensino
Recife, 50070-480
Centro de Tratamento de Tumores Botafogo
Rio de Janeiro, 22.250-905
Instituto D´or de Pesquisa e Ensino
Rio de Janeiro, 22281-100
Instituto de Educação, Pesquisa e Gestão em Saúde
Rio de Janeiro, 22793-080
NOB - Nucleo de Oncologia da Bahia
Salvador, Estado de Bahia, 40170-110
Ensino E Terapia de Inovação Clínica Amo - Ética
Salvador, Estado de Bahia, 41.830-492
Hospital Paulistano - INSTITUTO DE EDUCAÇÃO, PESQUISA E GESTÃO EM SAÚDE
São Paulo, 01323-000
Hcor - Associação Beneficente Síria
São Paulo, 04004-030
About this study
Official title: TREATMENT PATTERNS AND CLINICAL OUTCOMES AMONG PATIENTS IN BRAZIL RECEIVING PALBOCICLIB COMBINATIONS FOR HR+/HER2- ADVANCED/METASTATIC BREAST CANCER IN REAL WORLD SETTINGS
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.
Read the 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
- Keywords
- non-metastatic breast cancer, locally advanced (stage III) breast cancer, metastatic breast cancer (stage IV)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Patients | Eligible patients including patients with a potential follow-up period of 6 months following the index date |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start30 May 2022
- Primary completion2 May 2023
- Study completion2 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505175
- Sponsor's protocol ID
- A5481168
- Other IDs
- IRIS Brazil
- Status last verified
- Apr 2024
- First submitted
- 15 Aug 2022
- Last updated
- 2 Jun 2026
- Results posted
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TREATMENT PATTERNS AND CLINICAL OUTCOMES AMONG PATIENTS IN BRAZIL RECEIVING PALBOCICLIB COMBINATIONS FOR HR+/HER2- ADVANCED/METASTATIC BREAST CANCER IN REAL WORLD SETTINGS
- ClinicalTrials.gov ID
- NCT05505175
- Acronym / sponsor ID
- A5481168
- Conditions
- Breast Cancer, Breast Carcinoma
- Keywords
- non-metastatic breast cancer, locally advanced (stage III) breast cancer, metastatic breast cancer (stage IV)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 30 May 2022 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Patients | – | –Eligible patients including patients with a potential follow-up period of 6 months following the index date |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- Patients who were enrolled to receive fulvestrant but already received previous therapies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demographical characteristics of patients who have received palbociclib combination treatments in line with locally approved indications
Time frame: 30 days after prescribed palbociclib + partner therapy until completion of this study in 2022.
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.
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.
Time frame: 30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.
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.
Describe treatments received in the advanced/metastatic setting before palbociclib combination use
Time frame: 30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.
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.
Describe treatments received in the advanced/metastatic setting after palbociclib combination use
Time frame: 30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.
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.
Describe dosing associated with palbociclib use in clinical practice
Time frame: 30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.
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.
Describe dose changes associated with palbociclib use in clinical practice
Time frame: 30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.
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.
Describe interruptions associated with palbociclib use in clinical practice
Time frame: 30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.
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.
Describe delays associated with palbociclib use in clinical practice
Time frame: 30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.
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.
Describe discontinuations associated with palbociclib use in clinical practice
Time frame: 30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.
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.
Describe supportive therapies received by patients while receiving palbociclib combination treatments
Time frame: 30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.
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.
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
Time frame: 30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.
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.
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
Time frame: 30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.
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.
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
Time frame: 30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Breast Carcinoma, run by Pfizer at 14 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographical characteristics of patients who have received palbociclib combination treatments in line with locally approved indications (time frame: 30 days after prescribed palbociclib + partner therapy until completion of this study in 2022.). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.