Personalized Adaptive Novel Agents for Breast Cancer
(I-SPY Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing new medicines along with regular cancer treatment to find the best combinations for breast cancer patients. It focuses on identifying which treatments work best based on specific cancer characteristics. Early signs of success are monitored using MRI scans and tests on blood and tissue samples.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, you cannot use any investigational agents within 30 days of starting the study treatment.
Is the combination of abemaciclib with endocrine therapy safe for breast cancer treatment?
Abemaciclib, when combined with endocrine therapy, has been shown to improve outcomes in hormone receptor-positive, HER2-negative breast cancer, but it has different toxicity profiles that require careful monitoring. The safety profiles of these combinations are generally predictable and manageable, though there is an increased risk of potentially serious toxicities.12345
What makes the drug combination of Amcenestrant and Abemaciclib unique for breast cancer treatment?
The combination of Amcenestrant and Abemaciclib is unique because it targets hormone receptor-positive, HER2-negative breast cancer by combining a selective estrogen receptor degrader (Amcenestrant) with a CDK4/6 inhibitor (Abemaciclib), which has shown effectiveness in improving progression-free survival in advanced cases.16789
What data supports the effectiveness of the drug combination Amcenestrant + Abemaciclib for breast cancer?
Who Is on the Research Team?
Laura Esserman, MD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for adults over 18 with invasive breast cancer, who haven't had chemotherapy or radiation for it. They must be non-pregnant, have normal organ function, and no metal implants incompatible with MRI. The cancer should be measurable in the breast and not spread far (specific stages). All hormone receptor statuses are eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive novel investigational agents in sequence with standard chemotherapy to assess efficacy based on molecular characteristics
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Participants may continue to receive treatment with novel agents if they show a high probability of improved efficacy
What Are the Treatments Tested in This Trial?
Interventions
- Amcenestrant + Abemaciclib
- Amcenestrant + Letrozole
- Cemiplimab
- Cemiplimab plus REGN3767
- Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab
- Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab
- Pembrolizumab - 4 cycle
- Pembrolizumab - 8 cycle
- SD-101 + Pembrolizumab
Amcenestrant + Abemaciclib is already approved in United States, European Union for the following indications:
- Advanced breast cancer
- HR-positive, HER2-negative breast cancer
- Locally advanced or metastatic breast cancer
- HR-positive, HER2-negative breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
QuantumLeap Healthcare Collaborative
Lead Sponsor