1400 Participants Needed

Ribociclib + Hormone Therapy for Breast Cancer

(Adjuvant WIDER Trial)

Recruiting at 39 trial locations
NP
Overseen ByNovartis Pharmaceuticals
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Novartis Pharmaceuticals
Must be taking: Endocrine therapy
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human 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?

Research from the MONALEESA-2 trial shows that adding Ribociclib to Letrozole significantly improved the time patients lived without their cancer getting worse compared to Letrozole alone in women with advanced breast cancer.23489

Who Is on the Research Team?

NP

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

My cancer was surgically removed with clear margins and is stage II or III.
My bone marrow and organs are functioning well.
I can take care of myself and am up and about more than half of my waking hours.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

36 months
Monthly visits for ribociclib administration

Safety Follow-up

Safety follow-up call conducted 30 days after the last dose of study treatment

1 month

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

Up to 48 months

What Are the Treatments Tested in This Trial?

Interventions

  • Anastrozole
  • Goserelin
  • Letrozole
  • Leuprolide
  • Ribociclib
Trial Overview The trial is testing Ribociclib combined with standard endocrine therapies like Anastrozole, Letrozole, Leuprolide, Goserelin or Exemestane in patients with certain stages of early breast cancer. It aims to see if this combination improves survival without invasive breast cancer returning.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Ribociclib + endocrine therapyExperimental Treatment6 Interventions

Anastrozole is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Arimidex for:
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Approved in United States as Arimidex for:
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Approved in Canada as Arimidex for:
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Approved in Japan as Arimidex for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Published Research Related to This Trial

In the MONALEESA-7 trial involving 672 premenopausal women with advanced HR-positive breast cancer, ribociclib combined with endocrine therapy significantly improved progression-free survival (23.8 months) compared to placebo (13.0 months), indicating its efficacy as a first-line treatment option.
The safety profile of ribociclib was manageable, with common grade 3 or 4 adverse events like neutropenia occurring in 61% of patients, but no treatment-related deaths were reported, suggesting that while there are risks, the benefits may outweigh them for patients.
Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial.Tripathy, D., Im, SA., Colleoni, M., et al.[2022]
In the phase 3 MONALEESA-2 study involving 668 postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer, the combination of ribociclib (RIB) and letrozole (LET) significantly improved the duration of response (DoR) to 26.7 months compared to 18.6 months with placebo plus LET.
Patients receiving RIB also experienced greater tumor shrinkage and pain reduction, with 32% showing a significant tumor response at 8 weeks, reinforcing the efficacy of RIB plus LET as a first-line treatment option.
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.Janni, W., Alba, E., Bachelot, T., et al.[2019]
In the MONALEESA-2 study involving 213 US patients with hormone receptor-positive, HER2-negative advanced breast cancer, ribociclib combined with letrozole significantly improved progression-free survival (PFS) to 27.6 months compared to 15.0 months with letrozole alone, indicating its efficacy as a first-line treatment.
The most common side effects of ribociclib included neutropenia (72%), nausea (69%), and fatigue (60%), highlighting the importance of monitoring for these adverse events during treatment.
Efficacy and Safety of Ribociclib With Letrozole in US Patients Enrolled in the MONALEESA-2 Study.Yardley, DA., Hart, L., Favret, A., et al.[2020]

Citations

Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial. [2022]
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]
Efficacy and Safety of Ribociclib With Letrozole in US Patients Enrolled in the MONALEESA-2 Study. [2020]
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]
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]
FDA Approval: Ribociclib for the Treatment of Postmenopausal Women with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer. [2019]
Ribociclib in HR+/HER2- Advanced or Metastatic Breast Cancer Patients. [2020]
Complete Clinical Response in Locally Advanced Metastatic de novo Breast Cancer after Front-Line Treatment with Ribociclib/Letrozole within the RIBANNA Study. [2022]
Ribociclib for the first-line treatment of advanced hormone receptor-positive breast cancer: a review of subgroup analyses from the MONALEESA-2 trial. [2019]
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