A Phase IIIb Study to Characterize the Efficacy and Safety of Adjuvant Ribociclib Plus Endocrine Therapy in a Close-to-clinical Practice Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER)

Summary

The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).

Description

Eligibility

Age range

18–100 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Ribociclib

  Ribociclib 400 mg orally once daily on days 1-21 of a 28 day cycle followed by 7 days rest

• Drug
  Letrozole

  Letrozole 2.5 mg orally once daily continuously

• Drug
  Ansastrozole

  Anastrozole 1 mg orally once daily continuously.

• Drug
  Goserelin

  Goserelin administered subcutaneously at 3.6 mg once every 4 weeks if the one-month depot formulation is used or at 10.8 mg once every 3 months if the three-month depot formulation is used

• Drug
  Leuprolide

  Leuprolide administered subcutaneously at 3.75 mg once every 4 weeks if the one-month depot formulation is used or at 11.25 mg once every 3 months if the three-month depot formulation is used

• Drug
  Exemestane

  Exemestane 25 mg once daily continuously

Locations (207)