Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC

Sponsor
West German Study Group
Study ID
NCT04055493
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Breast Cancer Female

Eligibility Criteria

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

Interventions

Study Details

The study investigates, whether the patient group with intermediate-risk early breast cancer benefits from treatment with ribociclib in combination with endocrine therapy compared to standard-of-care chemotherapy (followed by adjuvant endocrine therapy).

Key Dates

Start date
Jul 2, 2019
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
1,684 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ribociclib plus ET
    Ribociclib 600mg / day over 26 cycles + endocrine treatment of physician´s choice
  • No Intervention: Standard-of-care chemotherapy
    Standard-of-care chemotherapy according to the clinical guidelines, e.g., of the Breast Committee of the German Gynecological Oncology Group (AGO), and regional prescribing information depending on patient's needs for 16-24 weeks,

Primary Outcome Measure

invasive disease-free survival (iDFS) [ Time Frame: at end of study, on average 5 years after start of treatment ]

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