A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

Conditions

• Early Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• Ribociclib — DRUG
  Ribociclib orally taken at 400 mg on days 1 to 21 of a 28-day cycle
• Endocrine Therapy (ET) — OTHER
  Endocrine Therapy (ET) will be administered according to the local clinical guidelines and current local prescribing information

Study Details

A phase III, multicenter, randomized, open-label trial to evaluate the efficacy and safety of ribociclib with Endocrine Therapy (ET) as an adjuvant treatment in women and men with Hormone Receptor positive (HR+), Human Epidermal Growth Factor Receptor 2 negative (HER2-) Early Breast Cancer (EBC).

Key Dates

Start date

Dec 7, 2018

Status verified

Mar 2026

Primary completion

May 29, 2030

Completion

May 29, 2030

Study Design

Enrollment

5,101 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ribociclib + Endocrine Therapy (ET)
  Eligible participants will receive Ribociclib 400 mg once daily on days 1 to 21 of a 28-day cycle, followed by 7 days off ribociclib (Days 22 to 28). And Endocrine Therapy (ET) consisting of: * For postmenopausal women: \- Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously. * For premenopausal women and men: * Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously, combined with: * Goserelin 3.6 mg subcutaneously once every 4 weeks.
• Active Comparator: Endocrine Therapy (ET)
  Eligible participants will receive Endocrine Therapy (ET) consisting of: * For postmenopausal women: \- Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously. * For premenopausal women and men: * Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously, combined with: * Goserelin 3.6 mg subcutaneously once every 4 weeks.

Primary Outcome Measure

Invasive Disease-Free Survival (iDFS) [ Time Frame: Up to approximately 139 months ]

Locations (73)

Find similar trials in Birmingham, AL

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• Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
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