Chemotherapy Omission in ER+/HER2- Breast Cancer With 1-3 Positive Lymph Nodes Receiving Extended Adjuvant Abemaciclib

Phase 3

Recruiting

• Conditions: Breast Cancer
• Interventions: Drug: 3-year abemaciclib without chemo; Drug: treatment of physician's choice

• Registration Number: NCT06341621
• Lead Sponsor: Fudan University

Brief Summary

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

Detailed Description

This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative endocrine-sensitive breast cancer with 1-3 positive lymph nodes receiving extended (3 year) adjuvant abemaciclib. In this study, patient eligible will be randomized into either endocrine drug plus 3-year adjuvant abemaciclib without chemotherapy or treatment of physician's choice (TPC).The safety and efficacy of each group will be assessed through invasive disease free survival (iDFS), disease-free survival (DFS), distant disease free survival (DDFS), overall survival (OS) and adverse effects (AE) as graded by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.

Study Timeline

• Study First Submitted: 2024-03-16
• Study First Submitted QC: 2024-03-26
• Status Verified: 2024-04
• Study Start: 2024-04-02
• Study First Posted: 2024-04-02
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10
• Primary Completion: 2027-02-25
• Study Completion: 2029-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1900

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
endocrine drug plus 3-year abemaciclib without chemo	3-year abemaciclib without chemo	aromatase inhibitors with or without GnRHa plus 3-year lower dose (100mg bid) abemaciclib without chemotherapy.
treatment of physician's choice	treatment of physician's choice	treatment of physician's choice, including whether to receive chemotherapy, the chemotherapy regimen and the endocrine therapy regimen.

Primary Outcome Measures

Name	Time	Method
Invasive disease free survival	5 year

Secondary Outcome Measures

Name	Time	Method
disease free survival	5 year
Time Frame: 5 years] 5. adverse effects adverse effects	5 year
distant disease free survival	5 year
overall survival	5 year

Trial Locations

Locations (1)

Zhimin Cancer Shao; 🇨🇳 Shanghai, China