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Withdrawn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

First listed
Mar 16, 2017
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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