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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.
Must not have
Patient has impairment of GI function or GI disease that may significantly alter the absorption of the oral trial treatments
Patient has received any CDK4/6 inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 91 months
Awards & highlights
No Placebo-Only Group
Pivotal 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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a digestive issue that affects how my body absorbs medication.
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I have been treated with a CDK4/6 inhibitor.
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I have received high doses of specific chemotherapy drugs.
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My breast cancer has spread beyond the regional lymph nodes or has come back after surgery.
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I have HIV, Hepatitis B, or Hepatitis C.
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I am not taking any strong medication or supplements that affect enzyme CYP3A4/5.
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I do not have uncontrolled heart problems or abnormal heart rhythms.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Invasive Disease-Free Survival (iDFS)
Secondary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~2420

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,916 Previous Clinical Trials
4,248,784 Total Patients Enrolled
Translational Research in OncologyOTHER
21 Previous Clinical Trials
1,576 Total Patients Enrolled

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
~974 spots leftby May 2026
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