MedTrace Logo

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

NCT03248427 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2021-03-17

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • SOLTI Breast Cancer Research Group

    lead OTHER

Principal Investigators

  • Aleix Prat, PhD · H.Clinic de Barcelona/

  • Joaquin Gavilá, MD · Fundación Instituto Valenciano de Oncología

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-13
Primary Completion
2019-06-10
Completion
2019-07-20

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03248427 on ClinicalTrials.gov