Clinical trial · Interventional
Chemotherapy Omission in ER+/HER2- Breast Cancer With 1-3 Positive Lymph Nodes Receiving Extended Adjuvant Abemaciclib
A Prospective, Randomized, Open-label, Multicenter Phase III Study to Explore Chemotherapy Omission in ER+/HER2-endocrine-sensitive Breast Cancer With 1-3 Positive Lymph Nodes Receiving Extended Adjuvant Abemaciclib
NCT06341621CI-TRIAL-00075900RainbowrecruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in ER+/HER2-endocrine-sensitive breast cancer with 1-3 positive lymph nodes receiving extended (3 year) adjuvant abemaciclib
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3-year abemaciclib without chemo | Drug | — | UNRESOLVED |
| treatment of physician's choice | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- endocrine drug plus 3-year abemaciclib without chemo
- description
- aromatase inhibitors with or without GnRHa plus 3-year lower dose (100mg bid) abemaciclib without chemotherapy.
- interventionNames
- Drug: 3-year abemaciclib without chemo
- type
- ACTIVE_COMPARATOR
- label
- treatment of physician's choice
- description
- treatment of physician's choice, including whether to receive chemotherapy, the chemotherapy regimen and the endocrine therapy regimen.
- interventionNames
- Drug: treatment of physician's choice
Primary outcomes (1)
- measure
- Invasive disease free survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * women aged 18-80 years old; * Patient has localized invasive breast carcinoma with1-3 positive lymph nodes, T1-T2,and is ER+/HER2- confirmed by histopathology after early breast cancer surgery#HER2-negative breast cancer (based on most recently analyzed biopsy) defined as a negative in situ hybridization test or an Immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH) . * ER≥50% * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; * Has adequate organ function meeting the following criteria: (1) adequate bone marrow function: hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 109 /L; platelet count ≥ 100 \* 109 /L; (2)adequate liver and kidney function: Alanine Aminotransferase (ALT) ≤ 3×upper limit of normal (ULN), Aspartate Aminotransferase (AST) ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serum creatinine ≤ 1×ULN#and with endogenous creatinine clearance rate of \>50 ml/min (Cockcroft-Gault formula). * Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up. Exclusion Criteria: * Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy#; * Has bilateral breast cancer; * Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ. * Has metastatic (Stage 4) breast cancer; * Has any ≥T3 lesion * Is pregnant, is breast feeding women, or women of childbearing age who cannot practice effective contraceptives; * Patients participating in other clinical trials at the same time; * Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) \< 50% (cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous of randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure\>150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension; * Has severe or uncontrolled infection; * the researchers judged patients to be unsuitable for the study.
References
Publications (0)
Data not yet available
No reference posted for this study.