Ribociclib + Endocrine Therapy for Breast Cancer
(NATALEE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness and safety of ribociclib (Kisqali) combined with endocrine therapy for treating early-stage, hormone receptor-positive (HR+) and HER2-negative breast cancer. Participants will receive either ribociclib with endocrine therapy or endocrine therapy alone. Ideal candidates have undergone surgery to remove breast cancer, show no signs of cancer spreading, and have hormone receptor-positive, HER2-negative breast cancer. As a Phase 3 trial, it represents the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, especially those that strongly affect liver enzymes (CYP3A4/5) or have a narrow safety margin. If you're on hormone replacement therapy or certain cancer prevention drugs, you may need to stop those as well.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that ribociclib, when combined with hormone therapy, is generally well-tolerated by patients with HR+/HER2- early breast cancer. Most side effects from ribociclib can be managed by adjusting the dose, allowing many patients to continue treatment. This suggests it is relatively safe for use.
Hormone therapy alone has long been a standard treatment for hormone receptor-positive breast cancer, indicating its safety for treating this type of cancer.
Overall, both treatments have demonstrated safety, with ribociclib's side effects being manageable and hormone therapy already established as a safe standard treatment.12345Why do researchers think this study treatment might be promising?
Ribociclib combined with endocrine therapy is unique because it targets the growth of cancer cells in a new way. Unlike standard treatments for breast cancer, which often rely solely on endocrine therapy to block hormones that fuel cancer growth, ribociclib is a CDK4/6 inhibitor. This means it specifically interrupts the cycle that cancer cells use to divide and multiply. Researchers are excited about this combination because it has the potential to enhance the effectiveness of endocrine therapy, offering a more powerful option for slowing the progression of the disease.
What evidence suggests that ribociclib with endocrine therapy could be an effective treatment for early breast cancer?
Research has shown that combining ribociclib with hormone therapy, which participants in this trial may receive, greatly improves outcomes for patients with HR+/HER2- early breast cancer. Studies have found that this combination helps patients live longer without cancer recurrence for at least five years. It also significantly delays cancer progression compared to other treatments. Overall, ribociclib plus hormone therapy appears to provide better long-term outcomes for patients with this type of breast cancer. Another group in this trial will receive endocrine therapy alone, serving as an active comparator.24678
Who Is on the Research Team?
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for adults with early-stage, hormone receptor-positive (HR+), HER2-negative breast cancer who've had surgery to remove the tumor and possibly chemotherapy or radiotherapy if needed. They should be in good physical condition (ECOG 0 or 1) and not have any severe medical conditions that could interfere with the trial. People can't join if they're pregnant, breastfeeding, have HIV/Hepatitis B/C, are on certain drugs affecting liver enzymes, or have had another cancer within the last two years.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ribociclib 400 mg once daily on days 1-21 of a 28-day cycle and endocrine therapy once daily continuously
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Endocrine Therapy
- Ribociclib
Endocrine Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Breast cancer
- Prostate cancer
- Endometrial cancer
- Ovarian cancer
- Breast cancer
- Prostate cancer
- Endometrial cancer
- Ovarian cancer
- Breast cancer
- Prostate cancer
- Endometrial cancer
- Ovarian cancer
- Breast cancer
- Prostate cancer
- Endometrial cancer
- Ovarian cancer
- Breast cancer
- Prostate cancer
- Endometrial cancer
- Ovarian cancer
- Breast cancer
- Prostate cancer
- Endometrial cancer
- Ovarian cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD
Translational Research in Oncology
Collaborator