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Hormone Therapy

Ribociclib + Endocrine Therapy for Breast Cancer (NATALEE Trial)

Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient has no contraindication for the adjuvant ET in the trial and is planned to be treated with ET for 5 years
Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 91 months
Awards & highlights

NATALEE Trial Summary

This trial is testing a new drug to see if it is effective and safe to use in patients with a certain type of breast cancer.

Who is the study for?
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.Check my eligibility
What is being tested?
The study is testing how well Ribociclib works alongside standard endocrine therapy as an additional treatment after surgery for breast cancer. It's a phase III trial where patients are randomly assigned to receive either this combination treatment or just endocrine therapy alone to compare effectiveness and safety.See study design
What are the potential side effects?
Ribociclib may cause side effects like low white blood cell counts which can lead to infection risk, tiredness, nausea, diarrhea, hair thinning and loss of appetite. Endocrine therapy might also cause hot flashes, joint pain and mood swings.

NATALEE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can safely receive hormone therapy for my condition and will be treated for 5 years.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am a woman aware of my menopausal status or I am a man.
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My breast cancer is hormone receptor positive.
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My breast cancer is not HER2-positive.
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I have tumor tissue saved from a previous surgery.
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My surgery removed the tumor completely and I am in stage II or III.
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I am fully active or can carry out light work.
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I am 18 years old or older.

NATALEE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 91 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 91 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Invasive Disease-Free Survival (iDFS)
Secondary outcome measures
Change from baseline in the global health status Quality of life scale score as assessed by EORTC QLQ-C30
Change from baseline in the physical functioning sub-scale score as assessed by EORTC QLQ-C30
Distant disease-free survival (DDFS)
+3 more

NATALEE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Ribociclib + Endocrine TherapyExperimental Treatment2 Interventions
Participants will receive ribociclib 400 mg once daily on days 1-21 of a 28-day cycle and endocrine therapy once daily continuously
Group II: Endocrine TherapyActive Control1 Intervention
Participants will receive endocrine therapy only once daily continuously
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ribociclib
2018
Completed Phase 3
~2330

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,192,249 Total Patients Enrolled
88 Trials studying Breast Cancer
37,812 Patients Enrolled for Breast Cancer
Translational Research in OncologyOTHER
21 Previous Clinical Trials
1,576 Total Patients Enrolled
3 Trials studying Breast Cancer
77 Patients Enrolled for Breast Cancer

Media Library

Endocrine Therapy (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03701334 — Phase 3
Breast Cancer Research Study Groups: Ribociclib + Endocrine Therapy, Endocrine Therapy
Breast Cancer Clinical Trial 2023: Endocrine Therapy Highlights & Side Effects. Trial Name: NCT03701334 — Phase 3
Endocrine Therapy (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03701334 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

If this clinical trial is happening in more than one location, where are the sites?

"Currently, there are 94 clinical trial sites enrolling patients for this study. While the majority of these locations are in Vancouver, Salt Lake City and Kitchener, other cities are included too. If you're interested in participating, try to select a site that is close to your home to limit unnecessary travel."

Answered by AI

What are some of the risks associated with taking Endocrine Therapy medication?

"Endocrine Therapy has been studied in multiple Phase 3 trials, so there is some evidence of efficacy and extensive data supporting its safety."

Answered by AI

Is this the inaugural clinical trial for this treatment?

"Since 2012, Endocrine Therapy has been investigated in clinical trials. The first sponsor of such a trial was Pfizer in 2012 and since then there have been 54 active studies involving the drug. These studies are located across 565 cities and 56 countries."

Answered by AI

Can you name some other hormone-based therapies that have been trialed before?

"Endocrine Therapy was first researched in 2012 at Azienda Ospedaliera Universitaria Federico II. Since then, there have been 31 completed clinical trials with 54 more presently active and recruiting patients. Out of these active trials, many are based in Vancouver, British Columbia."

Answered by AI

What is the target number of participants for this experiment?

"At this moment, this clinical trial is not searching for new patients to enroll. According to the date stamps on the website, (12/7/2018 and 2/17/2022) this study was either completed or is no longer active. However, there are 2370 trials currently enrolling breast cancer patients and 54 endocrine therapy trials that are actively admitting participants."

Answered by AI

Are we currently enrolling patients in this clinical trial?

"This trial is no longer recruiting patients. The study began on December 7th, 2018 and was last updated February 17th, 2022. However, there are 2370 trials currently searching for breast cancer patients and 54 endocrine therapy trials that are still open to participants."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
65+
What site did they apply to?
St. Jude Heritage Medical Group Dept.of Virginia K Crosson Ctr
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer
2018. "A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03701334.
~1433 spots leftby May 2026
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