Ribociclib-endocrine Combination Therapy Versus Chemotherapy as 1st Line in Visceral mBC

Sponsor
Swiss Cancer Institute
Study ID
NCT03905343
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Ribociclib — DRUG
    Ribociclib 600mg p.o. d1-21, q4w in combination with endocrine treatment for 3 years.
  • Mono-chemotherapy — OTHER
    mono-chemotherapy for at least 12 weeks (afterwards, maintenance endocrine therapy ± ribociclib inhibitor is allowed) and up to 3 years.
  • Endocrine-Therapy — OTHER
    The choice of endocrine therapy is up to the investigator, but the chosen endocrine therapy has to be registered to be used in combination with ribociclib in the investigated indication.

Study Details

The aim of this trial is to assess if patients treated with the combination of ribociclib and endocrine therapy respond to treatment as fast as patients treated with chemotherapy only, without decreasing their quality of life (QoL).

Key Dates

Start date
Jun 25, 2019
Status verified
Jun 2021
Primary completion
Apr 15, 2021
Completion
Apr 15, 2021

Study Design

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

Arms

  • Experimental: A: endocrine therapy + ribociclib
  • Active Comparator: B: mono-chemotherapy

Primary Outcome Measure

Quality of life-adjusted early disease control [ Time Frame: at 12 weeks. ]

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