Ribociclib Combination Therapy for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This is an open-label, multi-center, roll-over study to evaluate the long term safety of ribociclib in combination with other drugs in participants who are participating in a Novartis sponsored global study, that has fulfilled requirements for its primary objective(s), and who in the opinion of the Investigator, would benefit from continued treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, since it involves continuing ribociclib treatment from a previous study, you may need to stay on this medication.
Is Ribociclib combination therapy safe for humans?
How is the Ribociclib combination drug unique for breast cancer treatment?
The Ribociclib combination drug is unique because it includes Ribociclib, a cyclin-dependent kinase 4/6 inhibitor, which when combined with letrozole, significantly improves progression-free survival in patients with hormone receptor-positive, HER2-negative advanced breast cancer, offering a substantial clinical benefit compared to letrozole alone.13678
What data supports the effectiveness of the drug Ribociclib in combination with other therapies for breast cancer?
Research from the MONALEESA-2 study shows that combining Ribociclib with Letrozole significantly improves progression-free survival (the time during and after treatment that a patient lives with the disease without it getting worse) in patients with hormone receptor-positive, HER2-negative advanced breast cancer compared to Letrozole alone.35678
Who Is on the Research Team?
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for breast cancer patients already in a Novartis study, who've seen benefits from Ribociclib and other drugs. They must have completed at least 6 cycles of treatment with Ribociclib. Those permanently off Ribociclib or with unresolved toxicities from it can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants continue receiving ribociclib in combination with other drugs as in the parent study
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Anastrozole
- Fulvestrant
- Goserelin
- Letrozole
- Ribociclib
- Tamoxifen
Anastrozole is already approved in European Union, United States, Canada, Japan for the following indications:
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