Observational study on treatment patterns in metastatic breast cancer in Brazil

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

This study looks at how patients in Brazil with hormone receptor-positive and HER2-negative metastatic breast cancer are treated and what their outcomes are, focusing on those who started treatment with CDK4/6 inhibitors.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: AstraZeneca (Industry-sponsored)
• Locations: 5 sites (Fortaleza and 4 other locations)
• Trial ID: NCT06676436 on ClinicalTrials.gov

What this trial studies

This observational study aims to generate Real-World Evidence (RWE) by evaluating treatment patterns and outcomes in patients with hormone receptor-positive and HER2-negative metastatic breast cancer in Brazil. The study will include a cohort of 200 patients who have received treatment at ten participating Brazilian centers since January 2018. Data will be collected from digital charts, focusing on patients who have been treated with CDK4/6 inhibitors as first-line therapy. The study does not test any hypotheses but seeks to describe real-world treatment experiences and outcomes.

Who should consider this trial

Good fit: Ideal candidates include adult patients with unresectable or metastatic breast cancer who are hormone receptor-positive and HER2-negative and have received CDK4/6 inhibitors as first-line treatment.

Not a fit: Patients with breast cancer who do not meet the hormone receptor-positive or HER2-negative criteria or have not received CDK4/6 inhibitors will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into effective treatment strategies for metastatic breast cancer, potentially improving patient outcomes.

How similar studies have performed: While this study is observational and descriptive, similar studies have successfully provided insights into treatment patterns and outcomes in cancer care.

Eligibility criteria

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.

Where this trial is running

Fortaleza and 4 other locations

• Research Site — Fortaleza, Brazil (Recruiting)
• Research Site — Porto Alegre, Brazil (Recruiting)
• Research Site — Salvador, Brazil (Recruiting)
• Research Site — São Paulo, Brazil (Recruiting)
• Research Site — São Paulo, Brazil (Not_yet_recruiting)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions Cancer; Breast