OncoMatch/Clinical Trials/NCT07237256
Chemotherapy De-escalation in HR +, HER2-, Intermediate-risk Early Breast Cancer Treated With Adjuvant Ribociclib
Is NCT07237256 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Chemotherapy followed by endocrine therapy and ribociclib treatment for breast cancer.
Treatment: Chemotherapy followed by endocrine therapy and ribociclib treatment — The advent of CDK4/6 inhibitors (drugs designed to block the action of CDK4/6 proteins, which play a key role in cell proliferation) has improved treatment prospects for patients with metastatic breast cancer whose tumour cells express hormone receptors but not the HER2 protein (HR+/HER2-). The NATALEE study showed that the addition of ribociclib for three years to conventional adjuvant hormone therapy (i.e. after surgery) prolonged survival free of invasive disease (i.e. extending to surrounding tissues) in patients with early HR breast cancer+ /HER2-. Unlike other studies, NATALEE included a group of patients at intermediate risk of recurrence, usually treated with adjuvant chemotherapy before receiving hormone therapy. However, the benefit of adjuvant chemotherapy in these patients is uncertain. The hypothesis of the NoLEEta study is that by using the CDK 4/6 inhibitor, patients could avoid adjuvant chemotherapy and therefore be spared the side-effects associated with this chemotherapy, without reducing the efficacy of the treatment.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (≥10% ER staining)
ER-positive (with tumor cells showing ≥10% ER staining)
Required: HER2 (ERBB2) negative (HER2-negative according to the most recent ASCO/CAP guidelines)
HER2-negative according to the most recent ASCO/CAP guidelines
Disease stage
Required: Stage PT2 PN0 GRADE 3, PT2 PN0 GRADE 2 WITH KI67≥20%, PT0-2 PN1, PT3-4 PN0 (AJCC 8th edition)
Excluded: Stage IV
Pathological stage (8th edition of the AJCC), including pT2 pN0 Grade 3 or pT2 pN0 Grade 2 with Ki67≥20% or pT0-2 pN1 or pT3-4 pN0
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: surgery — curative
Curative surgery for the invasive disease must have been performed with negative surgical margins within 12 weeks before randomization. If positive surgical margins, patients are eligible if revision surgery or other adequate local treatment (i.e local radiotherapy) is planned.
Cannot have received: neoadjuvant chemotherapy
Patient has received any neoadjuvant chemotherapy since her breast cancer diagnosis
Cannot have received: CDK4/6 inhibitor
Patient has received any prior CDK4/6 inhibitor
Cannot have received: endocrine therapy for chemoprevention or osteoporosis (tamoxifen, raloxifene, aromatase inhibitors)
Breast cancer diagnosed while patient was receiving tamoxifen, raloxifene or aromatase inhibitors (AIs) for reduction in risk ("chemoprevention") of breast cancer and/or treatment for osteoporosis within the last 2 years prior to randomization.
Lab requirements
Blood counts
ANC ≥1.5 x 10⁹/L; Platelet count ≥100 x 10⁹/L; Hemoglobin ≥9 g/dL
Kidney function
Serum creatinine ≤1.5 mg/dL or calculated creatinine clearance ≥60 mL/min/1.73m² (CKD-EPI equation (2021))
Liver function
Total bilirubin < ULN (≤3 x ULN for Gilbert syndrome or direct bilirubin ≤1.5 x ULN); ALT and AST <2.5 x ULN
Cardiac function
QTcF interval < 450 ms; Resting heart rate 50-100 bpm
Adequate hematological, renal, and hepatic function, as outlined below: ... Standard 12-lead ECG values assessed, as: QTcF interval (QT interval using Fridericia's correction) at screening < 450 milliseconds (msec); Resting heart rate 50-100 beats per minute (determined from the ECG)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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