CDK4/6 Inhibitor + Fulvestrant for Breast Cancer
(AIM-BRIGHT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if an artificial intelligence model can identify patients with advanced breast cancer who might benefit from a second CDK4/6 inhibitor treatment combined with fulvestrant, after the first treatment proved ineffective. Researchers seek to discover if this combination can slow cancer progression more effectively than other treatments. The trial targets individuals with hormone receptor-positive (HR+) and HER2-negative advanced breast cancer who have experienced cancer progression after at least six months on a prior CDK4/6 inhibitor. Participants will receive either the second CDK4/6 inhibitor (a type of cancer drug) with fulvestrant or a treatment chosen by their doctor, with monthly check-ups. Ideal participants have previously tried a CDK4/6 inhibitor and can access necessary treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to advancing cancer treatment.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, if you are on any investigational drugs that interact with the trial drugs, you must stop them at least 3 weeks before enrolling. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining CDK4/6 inhibitors with fulvestrant has been tested in breast cancer patients. One study found that using abemaciclib (a type of CDK4/6 inhibitor) with fulvestrant extended the time patients lived without their cancer worsening. This suggests the combination is effective and generally well-tolerated.
Regarding safety, studies have examined how patients cope with these treatments. No major differences in survival rates have been observed among different CDK4/6 inhibitors, indicating similar safety profiles. Many patients tolerate these drugs well, although some side effects may occur.
In summary, past studies suggest this treatment combination is generally safe, and many patients manage it without serious issues.12345Why do researchers think this study treatment might be promising for breast cancer?
Researchers are excited about the combination of a new CDK4/6 inhibitor with fulvestrant for breast cancer because it offers a fresh approach after initial treatments. Most current therapies, like other CDK4/6 inhibitors paired with hormone therapies, aim to stop cancer cell growth by targeting specific proteins. This study treatment introduces a different CDK4/6 inhibitor than what patients might have first received, potentially overcoming resistance and offering renewed effectiveness. Additionally, the option to tailor treatment choices to exclude CDK4/6 inhibitors, based on physician discretion, allows for personalized care strategies. This approach could provide new hope and better outcomes for patients who have developed resistance to initial therapies.
What evidence suggests that this trial's treatments could be effective for advanced breast cancer?
In this trial, participants will receive either a second CDK4/6 inhibitor with fulvestrant or a treatment of the physician's choice, excluding CDK4/6 inhibitors. Studies have shown that using a second CDK4/6 inhibitor with fulvestrant, a type of hormonal therapy, can effectively manage advanced breast cancer when the first CDK4/6 treatment stops working. Research indicates that this combination can significantly delay cancer progression, especially in patients whose cancer has spread only to the bones. Patients receiving this combination treatment experienced longer periods before needing additional therapies compared to other treatment options. This suggests that the combination not only helps control cancer but may also be more effective than chemotherapy after the initial CDK4/6 treatment. Overall, this approach highlights the potential benefits of continuing CDK4/6 inhibitors with fulvestrant for patients whose cancer progresses after their initial treatment.678910
Who Is on the Research Team?
Kay Yeung, MD, PhD
Principal Investigator
University of California, San Diego
Are You a Good Fit for This Trial?
This trial is for individuals with advanced breast cancer that's hormone receptor positive (HR+) and HER2-. They must have previously progressed on a CDK4/6 inhibitor. The study uses an AI model to predict who might benefit from a second CDK4/6 inhibitor plus fulvestrant, compared to treatment chosen by their physician.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a second CDK4/6 inhibitor plus fulvestrant or treatment of physician's choice
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- A CDK4/6 inhibitor different from the first that the participant had received
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor