Ribociclib + Hormone Therapy for Breast Cancer
(Adjuvant WIDER Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you can continue using standard endocrine therapy (hormone treatment) like tamoxifen or toremifene. It's best to discuss your specific medications with the trial team.
Is Ribociclib with hormone therapy safe for breast cancer treatment?
Ribociclib, when combined with hormone therapy like 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.12345
What makes the drug Ribociclib combined with hormone therapy unique for breast cancer treatment?
Ribociclib, when combined with hormone therapy like letrozole, is unique because it significantly improves progression-free survival in patients with hormone receptor-positive, HER2-negative advanced breast cancer, compared to hormone therapy alone. This combination targets specific proteins (CDK 4/6) that help cancer cells grow, offering a novel approach to slowing down the disease.23678
What data supports the effectiveness of the drug Ribociclib plus hormone therapy for breast cancer?
Who Is on the Research Team?
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Are You a Good Fit for This Trial?
Adults over 18 with HR-positive, HER2-negative early breast cancer that's been surgically removed and has no tumor at the margins. They should have started hormone therapy within the last 24 months and must continue it for at least another 3 years. Good performance status (able to carry out daily activities) and proper organ function are required.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ribociclib 400 mg orally once daily on days 1 to 21 of a 28-day cycle, in combination with daily endocrine therapy for 36 months
Safety Follow-up
Safety follow-up call conducted 30 days after the last dose of study treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment until death, withdrawal of consent, lost to follow-up, or 48 months after the last participant's first dose
What Are the Treatments Tested in This Trial?
Interventions
- Anastrozole
- Goserelin
- Letrozole
- Leuprolide
- Ribociclib
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