← Back to Search

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

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

Select...

I can safely receive hormone therapy for my condition and will be treated for 5 years.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

I am a woman aware of my menopausal status or I am a man.

Select...

My breast cancer is hormone receptor positive.

Select...

My breast cancer is not HER2-positive.

Select...

I have tumor tissue saved from a previous surgery.

Select...

My surgery removed the tumor completely and I am in stage II or III.

Select...

I am fully active or can carry out light work.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a digestive issue that affects how my body absorbs medication.

Select...

I have been treated with a CDK4/6 inhibitor.

Select...

I have received high doses of specific chemotherapy drugs.

Select...

My breast cancer has spread beyond the regional lymph nodes or has come back after surgery.

Select...

I have HIV, Hepatitis B, or Hepatitis C.

Select...

I am not taking any strong medication or supplements that affect enzyme CYP3A4/5.

Select...

I do not have uncontrolled heart problems or abnormal heart rhythms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 91 months

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

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

0 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,889 Previous Clinical Trials

4,196,903 Total Patients Enrolled

88 Trials studying Breast Cancer

37,756 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

~1146 spots leftby May 2026

Unbiased ResultsWe believe in providing patients with all the options.

Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.

Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.