OncoMatch/Clinical Trials/NCT05296746

Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer

Is NCT05296746 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Ribociclib (neoadjuvant) and Chemotherapy (adjuvant) for breast cancer stage ii.

Phase 2RecruitingSOLTI Breast Cancer Research GroupNCT05296746Data as of May 2026

Treatment: Ribociclib (neoadjuvant) · Chemotherapy (adjuvant) · Ribociclib (adjuvant) — This is an open-label, multicenter international trial in men and women with primary operable HR+/HER2-, ki67≥20%, grade 2 or 3 and stage II breast cancer to evaluate safety and long-term efficacy of a non-chemo treatment in patients biologically responders to neoadjuvant ribociclib and letrozole. This study aims to evaluate whether chemotherapy could be avoided for initial high-risk clinicopathological breast cancer patients that are converted to low genomic risk assessed by Risk of Recurrence-low (ROR-low) at 6 months of letrozole - ribociclib neoadjuvant treatment by continuing with this treatment in adjuvant setting.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: ESR1 overexpression (>10% ER staining)

ER-positive/HER2-negative according to the most recent ASCO/CAP guidelines assessed locally, tumor cells >10% ER staining

Required: HER2 (ERBB2) wild-type

ER-positive/HER2-negative according to the most recent ASCO/CAP guidelines assessed locally

Required: MKI67 overexpression (Ki-67 index ≥20%)

Ki-67 index by local analysis of ≥20% on untreated tumor tissue

Disease stage

Required: Stage II

Excluded: Stage I, III, IV

Grade: 23

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: any treatment for primary invasive breast cancer

Exception: Letrozole or other drugs used during the preservation of ovarian function are permitted if administered after baseline biopsy

Any prior treatment for primary invasive breast cancer. Letrozole or other drugs used during the preservation of ovarian function are permitted if administered after baseline biopsy.

Lab requirements

Blood counts

Absolute neutrophil count (ANC) ≥1.5 x 10^9/L; Platelet count ≥100 x 10^9/L; Hemoglobin ≥10 g/dL

Kidney function

Serum creatinine ≤1.5 mg/dL or calculated creatinine clearance ≥60 mL/min (Cockcroft-Gault Equation)

Liver function

Alkaline phosphatase (AP) ≤2.5x ULN; Total bilirubin <ULN (≤3x ULN for Gilbert syndrome or direct bilirubin ≤1.5x ULN); ALT and AST <2.5x ULN

Cardiac function

LVEF ≥50%; no history of acute coronary syndromes within 12 months; no NYHA III-IV heart failure; no cardiomyopathy; no clinically significant arrhythmias; no long QT syndrome; QTc ≤500 msec; no uncontrolled hypertension (SBP >160 or <90 mmHg and/or DBP >100 mmHg)

Adequate hematological, renal and hepatic function, as follows: ... See full criteria for details. Cardiac exclusion criteria specified.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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