The main results of the CORALLEEN neoadjuvant phase II study have been previously reported28 (link). This study is registered with ClinicalTrials.gov, number NCT03248427, and it is completed. The CORALLEEN trial was conducted under Good Clinical Practice guidelines and the Declaration of Helsinki, and the study protocol was approved by independent ethic committee of Hospital Vall d’Hebron. All patients provided written informed consent.
Briefly, postmenopausal women aged 18 years or older were accrued in this prospective, multicentric, randomized, parallel, non-comparative phase II clinical trial if they had an HR+/HER2− stage I-IIIA breast tumor with primary tumor size of at least 2 cm in diameter by magnetic resonance imaging (MRI) and a Prosigna®-defined Luminal B intrinsic subtype).
A total of 106 eligible patients were randomized in a 1:1 ratio to (A) ribociclib plus letrozole, or (B) multi-agent chemotherapy. Randomization was stratified based on tumor size (T3 vs. T1/T2) and nodal involvement (yes vs. no). Patients randomized to arm A received 28-day cycles of continuous daily letrozole, 2.5 mg per day, and ribociclib, 600 mg per day, according to a 3 weeks on/1 week off schedule, for a total duration of 24 weeks. Dose modifications were allowed to manage grade 2 or higher non-hematological adverse events and grade 3–4 hematological events. Two levels of dose reduction for ribociclib were prespecified: 400 mg/day on the first reduction and 200 mg/day on the second reduction. Patients discontinuing ribociclib treatment due to treatment-related toxicity could continue the active treatment phase of the study, receiving letrozole monotherapy as per the investigator’s discretion. Patients randomized to the standard chemotherapy arm received four cycles of doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2 administrated intravenously every 21 days, followed by weekly paclitaxel 80 mg/m2 intravenously for 12 weeks (AC-T). Surgery was done within 7 days after the last dose of ribociclib or 14 days after the last dose of chemotherapy. In the ribociclib plus letrozole group, letrozole was continued until the day of surgery. Tumor samples were collected according to protocol at baseline, day 14, and surgery, and subsequently formalin-fixed paraffin-embedded (FFPE).
Briefly, postmenopausal women aged 18 years or older were accrued in this prospective, multicentric, randomized, parallel, non-comparative phase II clinical trial if they had an HR+/HER2− stage I-IIIA breast tumor with primary tumor size of at least 2 cm in diameter by magnetic resonance imaging (MRI) and a Prosigna®-defined Luminal B intrinsic subtype).
A total of 106 eligible patients were randomized in a 1:1 ratio to (A) ribociclib plus letrozole, or (B) multi-agent chemotherapy. Randomization was stratified based on tumor size (T3 vs. T1/T2) and nodal involvement (yes vs. no). Patients randomized to arm A received 28-day cycles of continuous daily letrozole, 2.5 mg per day, and ribociclib, 600 mg per day, according to a 3 weeks on/1 week off schedule, for a total duration of 24 weeks. Dose modifications were allowed to manage grade 2 or higher non-hematological adverse events and grade 3–4 hematological events. Two levels of dose reduction for ribociclib were prespecified: 400 mg/day on the first reduction and 200 mg/day on the second reduction. Patients discontinuing ribociclib treatment due to treatment-related toxicity could continue the active treatment phase of the study, receiving letrozole monotherapy as per the investigator’s discretion. Patients randomized to the standard chemotherapy arm received four cycles of doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2 administrated intravenously every 21 days, followed by weekly paclitaxel 80 mg/m2 intravenously for 12 weeks (AC-T). Surgery was done within 7 days after the last dose of ribociclib or 14 days after the last dose of chemotherapy. In the ribociclib plus letrozole group, letrozole was continued until the day of surgery. Tumor samples were collected according to protocol at baseline, day 14, and surgery, and subsequently formalin-fixed paraffin-embedded (FFPE).
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