Observational Study on the Treatment of Patients With Metastatic Breast Cancer (NCT06676436) | Clinical Trial Compass
CompletedNot Applicable
Observational Study on the Treatment of Patients With Metastatic Breast Cancer
Brazil204 participantsStarted 2024-11-30
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients by drug class and treatment line
Timeframe: through study completion, an average of 1 year"