Brazilian breast cancer study reveals Real-World treatment trends
NCT ID NCT06676436
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at medical records of 204 Brazilian adults with a specific type of advanced breast cancer (HR+/HER2-). The goal was to see which treatments doctors actually use and how patients fare. No new treatments were tested; instead, researchers collected information to understand real-world care patterns.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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204 people
The number who actually took part.
- Started
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Nov 2024
- Finished
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Dec 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This study will consist of a convenience cohort; it will include 200 patients. Adult patients who had received treatment in the participant Brazilian centers, with mBC ER-positive (i.e. ER ≥ 1%) and HER2-negative (i.e. HER2 IHC 0, 1 or 2+ with negative ISH), and who had received any CDK4/6i as first-line treatment with any outcome (death, progressive disease, or drug interruption due to any cause) since January 2018 will be enrolled.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient or next of kin/legal representative willing and able to provide written informed consent according to the local regulations unless a waiver is granted by the local IRB/IEC/EC; * Adult female or male patients ≥18 years old; * Unresectable or metastatic breast cancer; Estrogen Receptor ≥ 1% at the moment first-line treatment was initiated, either in a biopsy immediately before starting treatment for metastatic disease or in the biopsy of initial breast cancer diagnosis if a new biopsy was not performed; * HER2-negative (IHC 0, 1+ or 2+/ISH negative) at the moment first-line treatment was initiated, either in a biopsy immediately before starting treatment for metastatic disease or in the biopsy of initial breast cancer diagnosis if a new biopsy was not performed; * Have received treatment with a CDK4/6i in the first-line treatment for unresectable or metastatic breast cancer; * Have discontinued permanently the treatment with CDK4/6 for any reason: progressed disease on first-line treatment, died during first-line treatment due to any cause, or interrupted treatment for any reason; * Patients with recurrent disease are not mandated to have a new biopsy at the time of recurrence Exclusion Criteria: \- Patients with recurrent disease with a primary tumor showing a different pattern of receptors (i.e. initial BC other than ER ≥ 1% and HER2 negative (IHC 0, 1+ or 2+/ISH negative); * Patients with a concomitant cancer at the time of the diagnosis of MBC HR-positive HER2-negative except for the non-metastatic non-melanoma skin cancers, or in situ or benign neoplasms; a cancer is considered concomitant if it occurs within 5 years of HR-positive HER2-negative BC diagnosis; * Patients who at time of data collection for this study are participating or have participated in an interventional study that remains blinded.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site
Fortaleza, Brazil
-
Research Site
Porto Alegre, Brazil
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Research Site
Salvador, Brazil
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Research Site
São Paulo, Brazil
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