Observational Study on the Treatment of Patients With Metastatic Breast Cancer

Launched by ASTRAZENECA · Nov 4, 2024

Keywords

ClinConnect Summary

This clinical trial is an observational study that aims to gather real-world information about how women in Brazil are treated for metastatic breast cancer that cannot be surgically removed. Specifically, the study is looking at women who have hormone receptor-positive breast cancer that has spread, and who have been treated with a certain type of medication called CDK4/6 inhibitors. Unlike traditional trials, this study is not testing new treatments or comparing them; instead, it is focused on understanding the treatment patterns and outcomes based on the experiences of patients who have already been treated.

To be eligible for this study, participants must be adult women aged 18 or older who have been diagnosed with metastatic or unresectable breast cancer that is hormone receptor-positive and HER2-negative. They should have received treatment with a CDK4/6 inhibitor and must have stopped this treatment for any reason. Participants will need to provide consent for their information to be used in the study, and they can expect to share their treatment history and outcomes. This study is currently recruiting participants, and it's important to note that women with other types of concurrent cancers or those currently involved in other blinded studies will not be eligible.

Gender

FEMALE

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.