Neadjuvant Multi-agent Chemotherapy or Letrozole Plus Ribociclib in Luminal B/HER2-negative Breast Cancer.

Sponsor
SOLTI Breast Cancer Research Group
Study ID
NCT03248427
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ribociclib — DRUG
    Ribociclib flat-fixed dose of 600 mg daily (three 200-mg capsules), days 1 to 21 of a 28-days cycle.
  • Letrozole 2.5mg — DRUG
    Daily continuous
  • Doxorubicin — DRUG
    60 mg/m2 as a continuous IV perfusion
  • Cyclophosphamide — DRUG
    600 MG/M2 in a 30 minutes IV infusion
  • Paclitaxel — DRUG
    80 mg/m2, in one hour IV infusion

Study Details

CORALLEEN is a two-arm, randomized, multicentric study in postmenopausal women with primary HR+/HER2 negative Luminal B breast cancer that will explore if the combination of ribociclib with letrozole offers clinical benefit at least comparable to that of standard chemotherapy.

Key Dates

Start date
Jul 13, 2017
Status verified
Mar 2021
Primary completion
Jun 10, 2019
Completion
Jul 20, 2019

Study Design

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

Arms

  • Experimental: Ribociclib + Letrozol
    Ribociclib: 600mg, 3-weeks-on/-week-off treatment Letrozole: 2.5mg daily; Six 28 days cycles
  • Other: Chemotherapy
    Chemotherapy treatment will consist of four cycles of AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 every 21 days) followed by weekly paclitaxel during 12 weeks.

Primary Outcome Measure

Rate of ROR-low according to the Prosigna test. [ Time Frame: 24 weeks ]

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