NATALEE : A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negartive Early Breast Cancer (New Adjuvant TriAl With Ribociclib

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Breast<br/>CancersCancer LocationBreast
Cancers

Systemic therapy | BreastBreast

Trial Overview Read MoreRead more

This phase III trial evaluating the safety and effectiveness of a targeted (biological) therapy (Ribociclib) with an endocrine therapy as an adjuvant treatment for people with hormone receptor positive (HR+) and HER2- breast cancer.
 

This trial is treating patients with breast cancer (HR+ / HER2-).

This is a systemic therapy trial.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negartive Early Breast Cancer (New Adjuvant TriAl With Ribociclib

Commercial Sponsor

Novartis Pharmaceuticals

Summary

Eligible patients enrolled in the Experimental Arm of this trial, will receive 400mg Ribociclib, once daily on days 1-21 of a 28 day cycle, followed by 7-days off and endocrine therapy continuously, once a day. Participants in the Comparator Arm of the trial will receive endocrine therapy only.

Recruiting Hospitals Read MoreRead more

Goulburn Valley Health
Shepparton
Ms Carole Mott
oncologyclinicaltrials@gvhealth.org.au
(03) 5832 3777

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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