Ribociclib + Endocrine Therapy for Breast Cancer
(NATALEE Trial)

Recruiting in Palo Alto (17 mi)

+480 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novartis Pharmaceuticals

Stay on Your Current Meds

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2- Early Breast Cancer (EBC)

Eligibility Criteria

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.

Inclusion Criteria

I have finished all recommended chemotherapy before or after surgery.

I was diagnosed with invasive breast cancer less than 18 months ago.

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

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Exclusion Criteria

I am still experiencing side effects from my previous cancer treatments.

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

Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol

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Treatment Details

Interventions

Endocrine Therapy (Hormone Therapy)
Ribociclib (CDK4/6 Inhibitor)

Trial OverviewThe 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.

Participant Groups

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

Endocrine Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as Hormone Therapy for: