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NCT06676436Completed

Observational Study on the Treatment of Patients With Metastatic Breast Cancer

Real World Outcomes and Treatment Patterns in Brazilian Patients With Hormone Receptor Positive / HER2-negative Unresectable or Metastatic Breast Cancer

Source: ClinicalTrials.gov · Last updated 23 Jun 2026

Brief summary (registry, in English)

This is a descriptive, retrospective, observational study to generate Real-World Evidence (RWE). This study will evaluate the treatment patterns and outcomes with metastatic or unresectable hormone receptor-positive breast cancer in Brazil. No hypotheses will be tested.

Status (registry)
Completed
Study type
Observational
Enrollment
204 (actual)
First submitted
16 Oct 2024
Start date
30 Nov 2024
Primary completion date
31 Dec 2025
Lead sponsor
AstraZeneca
NCT number
NCT06676436

What you commit to

  • Study type: Observational
  • Participants enrolled: 204
  • From 30 Nov 2024 to the primary completion date, 31 Dec 2025
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;

Other illness

  • \- 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);

Other

  • Patients who at time of data collection for this study are participating or have participated in an interventional study that remains blinded.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
FortalezaBrazilUnknown status
-
Coordinator of this site? Confirm its status
Porto AlegreBrazilUnknown status
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Coordinator of this site? Confirm its status
SalvadorBrazilUnknown status
-
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.