NCT03248427

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

CORALLEEN: A Phase 2 Clinical Trial of Multi-agent Chemotherapy or Letrozole Plus Ribociclib (LEE011) as Neoadjuvant Treatment for Postmenopausal Patients With Luminal B/HER2-negative Breast Cancer.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: SOLTI Breast Cancer Research Group · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a parallel, two-arm, randomized 1:1, stratified by tumor size and nodal involvement, open-label, multicenter, exploratory study in postmenopausal women with primary operable HR+/HER2-negative Luminal B breast cancer according to PAM50 intrinsic subtype to evaluate the clinical benefit and biological effects of ribociclib combined with letrozole. The primary trial objective is to evaluate the ability of each treatment strategy to provide ROR-low score at surgery. Luminal B patients will be randomized 1:1 to either letrozole plus ribociclib or chemotherapy.Two weeks after the first administration of the assigned treatment, patients will undergo a biopsy to assess early biological response to treatment, at Ki67 protein and gene expression level. After finalization of the assigned neoadjuvant treatment, patients will undergo surgery. The primary endpoint, Rate of ROR-low (at surgery) after neoadjuvant treatment, according to the Prosigna test will be centrally assessed. Baseline, Day 15 and post-treatment (surgical) primary breast tumor tissue samples should be available for each patient for molecular characterization A post-surgery visit will be performed within 28 days (7 days) from surgery, and will mark the end of the study for that patient

Conditions

• Breast Cancer

Interventions

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

Timeline

• Start date: 2017-07-13
• Primary completion: 2019-06-10
• Completion: 2019-07-20
• First posted: 2017-08-14
• Last updated: 2021-03-17

Locations

21 sites across 1 country: Spain