Phase IIIb Study of Ribociclib + ET in Early Breast Cancer

Conditions

• Early Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• Ribociclib — DRUG
  Ribociclib 400 mg orally once daily on days 1-21 of a 28 day cycle followed by 7 days rest
• Letrozole — DRUG
  Letrozole 2.5 mg orally once daily continuously
• Ansastrozole — DRUG
  Anastrozole 1 mg orally once daily continuously.
• Goserelin — DRUG
  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
• Leuprolide — DRUG
  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
• Exemestane — DRUG
  Exemestane 25 mg once daily continuously

Study Details

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).

Key Dates

Start date

Feb 28, 2024

Status verified

Jun 2026

Primary completion

Sep 7, 2029

Completion

Sep 20, 2030

Study Design

Enrollment

1,400 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Ribociclib + endocrine therapy
  Participants will receive ribociclib 400 mg orally once daily on days 1 to 21 of a 28-day cycle, in combination with daily endocrine therapy (ET) for 36 months (approximately 39 cycles). ET consists of: * For postmenopausal women: letrozole 2.5 mg orally once daily continuously, anastrozole 1 mg orally once daily continuously, or exemestane 25 mg once daily continuously. * For pre/perimenopausal women, and men: letrozole 2.5 mg orally once daily continuously, anastrozole 1 mg orally once daily continuously, or exemestane 25 mg once daily continuously, combined with goserelin 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) or leuprolide 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)

Primary Outcome Measure

Invasive Breast Cancer Free Survival (iBCFS) rate at 3 years [ Time Frame: At 3 years ]

Central Contacts

• Novartis Pharmaceuticals
  1-888-669-6682
  [email protected]
• Novartis Pharmaceuticals
  +41613241111
  [email protected]

Locations (78)

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