Elacestrant vs Elacestrant + CDK4/6 Inhibitor for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new approach for treating estrogen receptor-positive (ER+) and HER2-negative breast cancer. Researchers aim to determine if the drug elacestrant is more effective alone or when combined with a CDK4/6 inhibitor, such as abemaciclib, palbociclib, or ribociclib. It targets individuals who have previously tried other treatments, including a CDK4/6 inhibitor, for their metastatic breast cancer, which has spread to other parts of the body. Participants must have this specific type of breast cancer and have undergone at least two prior endocrine therapies. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop all current medications, but there is a 14-day washout period required if you were previously on a CDK4/6 inhibitor before starting a different one in the study. Additionally, you cannot take strong or moderate CYP3A4 inducers or inhibitors.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found that elacestrant caused common side effects such as nausea, tiredness, vomiting, and diarrhea. These side effects are expected. When combined with CDK4/6 inhibitors like palbociclib, abemaciclib, or ribociclib, the side effects were similar to those seen with these drugs alone, with no additional side effects.
Research also shows that most people can handle the combination of elacestrant with these inhibitors without unexpected or severe reactions, indicating that the treatment is generally well-tolerated. These findings from earlier studies help predict current reactions to the treatment. For those considering joining a trial, these results suggest a manageable safety profile based on previous research.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for breast cancer because they offer new ways to tackle the disease. Elacestrant is a selective estrogen receptor degrader (SERD), which works differently from standard hormone therapies by directly targeting and breaking down estrogen receptors, potentially offering more effective control over cancer growth. The combination therapy adds a CDK4/6 inhibitor, like Palbociclib, Abemaciclib, or Ribociclib, which interfere with cancer cell division, aiming to enhance the effects of Elacestrant. This dual approach could offer a powerful option, especially for patients who may not respond to current hormone therapies.
What evidence suggests that this trial's treatments could be effective for breast cancer?
Research shows that elacestrant may effectively treat hormone receptor-positive metastatic breast cancer. In real-world studies, patients taking elacestrant experienced stable cancer for about 5 to 7 months. This trial will provide participants with either elacestrant alone or in combination with CDK4/6 inhibitors such as palbociclib, abemaciclib, or ribociclib. When combined with these inhibitors, elacestrant is generally well-tolerated and may yield better results. Early findings suggest that this combination might be more effective, especially for patients who have already tried other treatments. Overall, using elacestrant alone or with CDK4/6 inhibitors appears promising for treating this type of breast cancer.678910
Who Is on the Research Team?
William Gradishar, M.D.
Principal Investigator
Northwestern University
Are You a Good Fit for This Trial?
This trial is for adults with ER+/HER2- advanced or metastatic breast cancer who have tried at least two endocrine therapies, including a CDK4/6 inhibitor. They should be in good physical condition (ECOG 0 or 1), have no severe heart issues, and not be at immediate risk due to visceral spread. Participants must not have had recent chemotherapy, major surgery, or certain other treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either elacestrant monotherapy or combination therapy with a CDK4/6 inhibitor for each 28-day cycle until progressive disease or other criteria are met
Follow-up
Participants are monitored for survival and disease progression every 36 weeks for 2 years, then every 72 weeks up to 5 years
What Are the Treatments Tested in This Trial?
Interventions
- Abemaciclib
- Elacestrant
- Palbociclib
- Ribociclib
Elacestrant is already approved in United States, European Union for the following indications:
- ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
- ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor
National Cancer Institute (NCI)
Collaborator