Clinical Trial

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)

MOA: Aromatase inhibitor, CDK4/6 inhibitor, LHRH agonist

Key Eligibility Criteria:

• Participant has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer (BC)Participant has HER2- BC
• Participant has no contraindication to receive adjuvant ET in the study.
• Participant after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories:
  • Anatomic Stage Group III, or
  • Anatomic Stage Group IIB, or
  • A subset of Anatomic Stage Group IIA.
• Participant without distant metastases of BC beyond regional lymph nodes (Stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.
• Participant is not concurrently using other antineoplastic therapy with the exception of adjuvant ET.