NCT03248427

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Jul 2017

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

July 13, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 14, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2019

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

1.9 years

First QC Date

July 3, 2017

Last Update Submit

March 16, 2021

Conditions

Breast Cancer

Keywords

Breast CancerNeoadjuvantLuminal B tumorsRibociclib

Outcome Measures

Primary Outcomes (1)

  • Rate of ROR-low according to the Prosigna test.

    Rate of ROR-low after neoadjuvant treatment at surgery, according to the Prosigna test,as per central assessment

    24 weeks

Secondary Outcomes (7)

  • Tumor Overall response rate (ORR)

    24 weeks

  • pCR in the breast and axillary lymph nodes

    24 weeks

  • PEPI Score

    24 weeks

  • Residual Cancer Burden (RCB)

    24 weeks

  • Rate of breast conserving surgery (BCS)

    24 weeks

  • +2 more secondary outcomes

Study Arms (2)

Ribociclib + Letrozol

EXPERIMENTAL

Ribociclib: 600mg, 3-weeks-on/-week-off treatment Letrozole: 2.5mg daily; Six 28 days cycles

Drug: RibociclibDrug: Letrozole 2.5mg

Chemotherapy

OTHER

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.

Drug: DoxorubicinDrug: CyclophosphamideDrug: Paclitaxel

Interventions

RibociclibDRUG

Ribociclib flat-fixed dose of 600 mg daily (three 200-mg capsules), days 1 to 21 of a 28-days cycle.

Also known as: LEE011
Ribociclib + Letrozol
Letrozole 2.5mgDRUG

Daily continuous

Ribociclib + Letrozol
DoxorubicinDRUG

60 mg/m2 as a continuous IV perfusion

Chemotherapy
CyclophosphamideDRUG

600 MG/M2 in a 30 minutes IV infusion

Chemotherapy
PaclitaxelDRUG

80 mg/m2, in one hour IV infusion

Chemotherapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed Informed Consent Form prior to any study-specific procedure.
  • Female patients.
  • Post-menopausal status and age ≥18 years.
  • Histologically confirmed invasive breast carcinoma, with all the following characteristics:
  • Primary tumor ≥ 2cm in largest diameter as measured by breast MRI
  • Stage I to stage IIIA breast cancer
  • No evidence of distant metastasis (M0)
  • Breast cancer eligible for primary surgery.
  • Available pre-treatment FFPE core (Tru-cut) biopsy evaluable for PAM50 or possibility to obtain one. Minimal sample requirements are to have at least 2 tumor cylinders with a minimal tissue surface of 10 mm2 tissue, containing at least 10% tumor cells and having enough tissue to do at least 2 cuts of 10 micrometers each.
  • Luminal B subtype as per PAM50 analysis of pre-treatment sample.
  • ER-positive and/or PgR-positive and HER2-negative tumor by ASCO/CAP guidelines assessed locally.
  • In the case of a multifocal tumor (defined as the presence of two or more foci of cancer within the same breast quadrant), the largest lesion must be ≥ 2 cm and designated the "target" lesion for all subsequent tumor evaluations and HR+/HER2-negative status must be documented in all the tumor foci.
  • ECOG performance status of 0 or 1.
  • Adequate hematological, renal and hepatic function.
  • Ability and willingness to comply with study visits, treatment, testing and to comply with the protocol.

You may not qualify if:

  • Any prior treatment for primary invasive breast cancer.
  • Inoperable locally advanced or inflammatory (i.e., inoperable Stage III) breast cancer.
  • Metastatic (Stage IV) breast cancer.
  • Bilateral invasive breast cancer.
  • Multicentric breast cancer, defined as the presence of two or more foci of cancer in different quadrants of the same breast.
  • Patients who have undergone sentinel lymph node biopsy prior to study treatment.
  • Inability or unwillingness to swallow pills.
  • Malabsorption syndrome or other condition that would interfere with enteric absorption of study drugs.
  • Participation in a prior investigational study within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer.
  • Patient with a Child-Pugh score B or C.
  • Patient has active cardiac disease or a history of cardiac dysfunction including any of the following:
  • History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty or stenting) or symptomatic pericarditis within 12 months prior to screening.
  • History of documented congestive heart failure (New York Heart Association functional classification III-IV).
  • Documented cardiomyopathy.
  • Patient has a Left Ventricular Ejection Fraction (LVEF) \< 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO).
  • +23 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Hospital Clinic de Barcelona

Barcelona, Spain

Location

Hospital General de Catalunya

Barcelona, Spain

Location

Hospital Universitari Vall d' Hebron

Barcelona, Spain

Location

Institut Català d'Oncologia l'Hospitalet

Barcelona, Spain

Location

Consorcio Hospitalario Provincial de Castellón

Castelló, Spain

Location

Hospital San Pedro de Alcántara

Cáceres, Spain

Location

Fundació Privada Hospital Asil de Granollers

Granollers, Spain

Location

Centro Integral Oncologico Clara Campal

Madrid, Spain

Location

Centro Oncológico MD Anderson International España

Madrid, Spain

Location

Hospital Quirón Madrid

Madrid, Spain

Location

Hospital Rey Juan Carlos

Madrid, Spain

Location

Hospital Universitario 12 de octubre

Madrid, Spain

Location

Hospital Universitario Fundación de Alcorcón

Madrid, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

Location

Hospital Universitari Son Espases

Palma, Spain

Location

Complexo Hospitalario Universitario de Santiago

Santiago de Compostela, Spain

Location

Hospital Virgen del Rocío

Seville, Spain

Location

Hospital Virgen Macarena

Seville, Spain

Location

Fundación Instituto Valenciano de Oncología

Valencia, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, Spain

Location

Hospital Universitari Arnau de Vilanova de València

Valencia, Spain

Location

Related Publications (2)

  • Villacampa G, Falato C, Pare L, Hernando C, Arumi M, Saura C, Gomez G, Munoz M, Gil-Gil M, Izarzugaza Y, Ferrer N, Najera-Zuloaga J, Montano A, Ciruelos E, Gonzalez-Santiago S, Villagrasa P, Gavila J, Prat A, Pascual T. Pre-operative ribociclib plus letrozole versus chemotherapy: Health-related quality of life outcomes from the SOLTI CORALLEEN trial. Eur J Cancer. 2022 Oct;174:232-242. doi: 10.1016/j.ejca.2022.07.028. Epub 2022 Sep 5.

    PMID: 36067616DERIVED

  • Prat A, Saura C, Pascual T, Hernando C, Munoz M, Pare L, Gonzalez Farre B, Fernandez PL, Galvan P, Chic N, Gonzalez Farre X, Oliveira M, Gil-Gil M, Arumi M, Ferrer N, Montano A, Izarzugaza Y, Llombart-Cussac A, Bratos R, Gonzalez Santiago S, Martinez E, Hoyos S, Rojas B, Virizuela JA, Ortega V, Lopez R, Celiz P, Ciruelos E, Villagrasa P, Gavila J. Ribociclib plus letrozole versus chemotherapy for postmenopausal women with hormone receptor-positive, HER2-negative, luminal B breast cancer (CORALLEEN): an open-label, multicentre, randomised, phase 2 trial. Lancet Oncol. 2020 Jan;21(1):33-43. doi: 10.1016/S1470-2045(19)30786-7. Epub 2019 Dec 11.

    PMID: 31838010DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ribociclibLetrozoleDoxorubicinCyclophosphamidePaclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenes

Study Officials

  • Aleix Prat, PhD

    H.Clinic de Barcelona/

    PRINCIPAL INVESTIGATOR

  • Joaquin Gavilá, MD

    Fundación Instituto Valenciano de Oncología

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2017

First Posted

August 14, 2017

Study Start

July 13, 2017

Primary Completion

June 10, 2019

Study Completion

July 20, 2019

Last Updated

March 17, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(21)