Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- Intermediate Risk Early Breast Cancer

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03081234
Phase
PHASE3
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ribociclib — DRUG
    Ribociclib 600 mg daily on days 1 to 21 of a 28-day cycle for 26 cycles (approximately 24 months). Ribociclib will be supplied in the form of 200 mg tablets.
  • Placebo — DRUG
    Placebo 600 mg daily on days 1 to 21 of a 28-day cycle for 26 cycles (approximately 24 months). Placebo will be supplied in the form of 200 mg tablets.
  • Adjuvant endocrine therapy — DRUG
    Tamoxifen 20 mg daily, or letrozole 2.5 mg daily, or anastrozole 1 mg daily, or exemestane 25 mg daily (male patients will be treated with tamoxifen 20 mg daily) for a total duration of at least 60 months. In premenopausal women, adjuvant endocrine therapy may include GnRH agonist administered every 28 days.

Study Details

This is an international, multi-center, randomized, double-blinded, placebo-controlled clinical study evaluating the efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, intermediate risk breast cancer.

Key Dates

Start date
Mar 31, 2018
Status verified
Mar 2018
Primary completion
Nov 17, 2025
Completion
Nov 17, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ribociclib + adjuvant endocrine therapy
    Ribociclib in combination with standard adjuvant endocrine therapy
  • Active Comparator: Placebo + adjuvant endocrine therapy
    Placebo in combination with standard adjuvant endocrine therapy

Primary Outcome Measure

Invasive disease-free survival (iDFS) using STEEP criteria [ Time Frame: up to 90 months ]

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