Neadjuvant Multi-agent Chemotherapy or Letrozole Plus Ribociclib in Luminal B/HER2-negative Breast Cancer. (CORALLEEN)
|ClinicalTrials.gov Identifier: NCT03248427|
Recruitment Status : Active, not recruiting
First Posted : August 14, 2017
Last Update Posted : January 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Ribociclib Drug: Letrozole 2.5mg Drug: Doxorubicin Drug: Cyclophosphamide Drug: Paclitaxel||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Actual Study Start Date :||July 13, 2017|
|Actual Primary Completion Date :||August 10, 2019|
|Estimated Study Completion Date :||November 20, 2020|
Experimental: Ribociclib + Letrozol
Ribociclib: 600mg, 3-weeks-on/-week-off treatment Letrozole: 2.5mg daily; Six 28 days cycles
Ribociclib flat-fixed dose of 600 mg daily (three 200-mg capsules), days 1 to 21 of a 28-days cycle.
Other Name: LEE011
Drug: Letrozole 2.5mg
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.
60 mg/m2 as a continuous IV perfusion
600 MG/M2 in a 30 minutes IV infusion
80 mg/m2, in one hour IV infusion
- Rate of ROR-low according to the Prosigna test. [ Time Frame: 24 weeks ]Rate of ROR-low after neoadjuvant treatment at surgery, according to the Prosigna test,as per central assessment
- Tumor Overall response rate (ORR) [ Time Frame: 24 weeks ]Tumor overall objective response rate (ORR), defined as the sum of Partial Responses (PR) and Complete Responses (CR) according to RECIST v1.1, as per Investigator's assessments by breast MRI.
- pCR in the breast and axillary lymph nodes [ Time Frame: 24 weeks ]pCR is defined as the complete absence of invasive carcinoma in the breast and axillary lymph nodes on histological examination.
- PEPI Score [ Time Frame: 24 weeks ]Preoperative endocrine prognostic index (PEPI) score in the ribociclib plus letrozole treatment arm compared to historical values
- Residual Cancer Burden (RCB) [ Time Frame: 24 weeks ]Rate of residual cancer burden (RCB) score 0 or 1 (RCB0/1) after neoadjuvant treatment, according to the MD Anderson Cancer Center procedures, as per central assessment.
- Rate of breast conserving surgery (BCS) [ Time Frame: 24 weeks ]Rate of breast conserving surgery
- Decrease in Ki67 in both treatment arms. [ Time Frame: At baseline, in week 2, and pre-surgery ]Decrease in Ki67 in both treatment arms.
- Incidence, duration and severity of Adverse Events (AEs) [ Time Frame: Up to 24 weeks ]Incidence, duration and severity of Adverse Events (AEs) assessed by the NCI Common Terminology for Classification of Adverse Events (CTCAE) version 4.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248427
|Principal Investigator:||Aleix Prat, PhD||H.Clinic de Barcelona/|
|Principal Investigator:||Joaquin Gavilá, MD||Fundación Instituto Valenciano de Oncología|