Study on New Biomarker-Driven Treatments for Advanced Breast Cancer
Sponsor: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials ID:NCT07340541
This clinical trial is exploring new treatments for patients with specific types of advanced breast cancer, using biomarkers to guide therapy choices. The study involves collecting tumor and blood samples to help tailor treatments and improve outcomes.
Patient Parameters
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Program Overview
This study is testing new treatments for patients with advanced breast cancer that is either estrogen receptor-positive/hormone receptor-negative (ER+/HR-) or triple-negative (TN). The trial uses biomarkers, which are specific characteristics of the cancer, to decide the best treatment for each patient. Participants will provide tumor and blood samples before starting treatment and during the study to help monitor their progress. The goal is to find out if these biomarker-driven treatments can help control the cancer better than current options. Treatment will continue until the cancer progresses, side effects become too severe, or the doctor decides to stop.
Description
This trial is designed to test multiple new treatments at the same time, focusing on groups of patients identified by specific cancer characteristics, known as biomarkers. If a patient's cancer worsens, they may be eligible to try other treatments being tested in the study. The main goal is to see how long patients can live without their cancer getting worse.
The study aims to quickly apply new biomarker discoveries to improve treatment for advanced breast cancer. Currently, there are limited biomarkers to guide treatment for certain types of breast cancer, like triple-negative breast cancer (TNBC). This trial is pioneering a new approach for women with advanced breast cancer who have already tried one treatment but need another option.
Eligible participants are those with ER+/HER2- or triple-negative breast cancer that has spread and worsened after the first treatment. Patients with HER2+ cancer are not included because there are already effective treatments available for them.
Participants will receive standard treatment based on their cancer's biomarkers. Blood samples will be collected at specific times to help monitor the cancer's response to treatment. The study will continue until the cancer progresses, side effects become too severe, or the doctor decides to stop. Participants must agree to the main study protocol to join this specific part of the trial.
Eligibility Criteria
Inclusion Criteria
- Must provide written consent to join the study and allow access to personal health information.
- Must be willing and able to follow study procedures.
- Must be 18 years or older.
- Must have a performance status score of 0 to 2, indicating good overall health.
- Must meet all eligibility criteria of the main study protocol and have agreed to participate in it.
Exclusion Criteria
- Cannot have metastatic cancer that cannot be biopsied for research.
- Cannot have already started second-line treatment.
- Cannot have other health conditions that make participation unsafe, according to the treating doctor.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic | 55905 | Rochester | Minnesota |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | 27599-7305 | Chapel Hill | North Carolina |
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