Ribociclib Combination Therapy for Breast Cancer
Recruiting in Palo Alto (17 mi)
+64 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Novartis Pharmaceuticals
Must be taking: Ribociclib
Disqualifiers: Unresolved toxicities, others
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
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.
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.
12345Is Ribociclib combination therapy safe for humans?
Ribociclib, when combined with letrozole, has been shown to have a manageable safety profile in treating advanced breast cancer. Common side effects include low white blood cell counts, nausea, tiredness, diarrhea, hair loss, vomiting, constipation, headache, and back pain.
15678How 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.
12346Eligibility Criteria
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
Currently participating in a Novartis sponsored global study (parent study), receiving treatment with ribociclib in combination with other drugs, and the parent study has fulfilled its primary objective(s)
I have been treated with ribociclib for at least 6 cycles.
You are currently benefiting from the treatment according to the doctor.
Exclusion Criteria
I had to stop taking ribociclib due to side effects that haven't gone away.
I was permanently taken off ribociclib in a previous study.
I can get and afford ribociclib where I live.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants continue receiving ribociclib in combination with other drugs as in the parent study
Up to 5 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Open-label extension
Participants may opt into continuation of treatment long-term
Long-term
Participant Groups
The study tests the long-term safety of continued use of Ribociclib combined with Letrozole, Anastrozole, Goserelin, Tamoxifen, or Fulvestrant in those benefiting from it after completing primary objectives in an earlier Novartis trial.
1Treatment groups
Experimental Treatment
Group I: RibociclibExperimental Treatment6 Interventions
All participants will receive ribociclib in combination with other drugs at the same dose/schedule as in the parent study.
Anastrozole is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Arimidex for:
- Breast cancer
- Early breast cancer in postmenopausal women
🇺🇸 Approved in United States as Arimidex for:
- Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
- First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer
🇨🇦 Approved in Canada as Arimidex for:
- Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
- Treatment of postmenopausal women with hormone receptor-positive advanced breast cancer
🇯🇵 Approved in Japan as Arimidex for:
- Breast cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Valley Hospital Luckow PavillionParamus, NJ
Duly Health and CarePlainfield, IL
Ironwood Cancer and Research CentersChandler, AZ
Indiana University Health Goshen Center for CancerGoshen, IN
More Trial Locations
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Who Is Running the Clinical Trial?
Novartis PharmaceuticalsLead Sponsor
References
Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial. [2022]In MONALEESA-2, ribociclib plus letrozole showed improved progression-free survival compared with letrozole alone as first-line treatment for postmenopausal patients with hormone receptor (HR)-positive, HER2-negative, advanced breast cancer. MONALEESA-7 aimed to assess the efficacy and safety of ribociclib plus endocrine therapy in premenopausal women with advanced, HR-positive breast cancer.
Efficacy and Safety of Ribociclib With Letrozole in US Patients Enrolled in the MONALEESA-2 Study. [2020]Label="BACKGROUND">In the Mammary Oncology Assessment of LEE011's (Ribociclib's) Efficacy and Safety (MONALEESA-2) study, combination treatment with the selective inhibitor of cyclin-dependent kinases 4/6 ribociclib with letrozole significantly improved progression-free survival (PFS) versus letrozole alone in postmenopausal women with hormone receptor-positive HR+/HER2- advanced breast cancer (ABC). Herein we present results from the subset of US patients enrolled in MONALEESA-2.
Complete Clinical Response in Locally Advanced Metastatic de novo Breast Cancer after Front-Line Treatment with Ribociclib/Letrozole within the RIBANNA Study. [2022]Ribociclib is an orally bioavailable cyclin-dependent kinase 4/6 inhibitor. In combination with aromatase inhibitor letrozole, it has approval for treatment of hormone receptor positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. First-line therapy with ribociclib + letrozole significantly improves progression-free survival compared to placebo + letrozole in patients with HR+/HER2- advanced breast cancer. In patients with de novo advanced or metastatic breast cancer, ribociclib was able to provide substantial clinical benefit according to data from the MONALEESA-2 study.
First-line ribociclib plus letrozole in postmenopausal women with HR+ , HER2- advanced breast cancer: Tumor response and pain reduction in the phase 3 MONALEESA-2 trial. [2019]The phase 3 MONALEESA-2 study demonstrated that addition of ribociclib (RIB) to letrozole (LET) significantly improved progression-free survival (PFS) in patients (pts) with hormone receptor-positive (HR+), HER2-negative (HER2-) advanced breast cancer (ABC). Here, we evaluated duration of response (DoR), tumor shrinkage, PFS by treatment-free interval (TFI), and health-related quality of life (HRQoL).
Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. [2022]The phase III MONALEESA-2 study demonstrated significantly prolonged progression-free survival (PFS) and a manageable toxicity profile for first-line ribociclib plus letrozole versus placebo plus letrozole in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. Here, we report updated efficacy and safety data, together with exploratory biomarker analyses, from the MONALEESA-2 study.
Safety and Efficacy of Ribociclib in Combination with Letrozole in Patients with HR+, HER2- Advanced Breast Cancer: Results from the Italian Subpopulation of Phase 3b CompLEEment-1 Study. [2022]Ribociclib plus letrozole demonstrated manageable safety and efficacy profiles in hormone receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2-) advanced breast cancer (ABC) in the Phase 3b CompLEEment-1 trial.
FDA Approval: Ribociclib for the Treatment of Postmenopausal Women with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer. [2019]On March 13, 2017, the FDA approved ribociclib (KISQALI; Novartis Pharmaceuticals Corp.), a cyclin-dependent kinase 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer. The approval was based on a randomized, double-blind, placebo-controlled, international clinical trial (MONALEESA-2). A total of 668 patients were randomized to receive either ribociclib plus letrozole (n = 334) or placebo plus letrozole (n = 334). An improvement in progression-free survival (PFS) was observed in patients receiving ribociclib plus letrozole compared with patients receiving placebo plus letrozole [HR = 0.556; 95% confidence interval (CI), 0.429-0.720]. Overall response rate (ORR) in patients with measurable disease was 52.7% (95% CI, 46.6-58.9) in the ribociclib plus letrozole arm and 37.1% (95% CI, 31.1-43.2) in the placebo plus letrozole arm. Overall survival data were immature. The most common adverse reactions observed in 20% or more of patients taking ribociclib were neutropenia, nausea, fatigue, diarrhea, leukopenia, alopecia, vomiting, constipation, headache, and back pain. This article summarizes FDA decision-making and data supporting the approval of ribociclib. Clin Cancer Res; 24(13); 2999-3004. ©2018 AACRSee related commentary by Spring and Bardia, p. 2981.
Ribociclib in HR+/HER2- Advanced or Metastatic Breast Cancer Patients. [2020]To review the chemistry, pharmacology, pharmacokinetics, safety, and efficacy of ribociclib (LEE011, Kisqali) in hormone receptor-positive/human epidermal growth factor receptor-2-negative (HR+/HER2-) metastatic breast cancer.