Breast Cancer
Conditions
Keywords
adjuvant chemotherapy omission, adjuvant abemeciclib
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.
Interventions
DRUG3-year abemaciclib without chemo
aromatase inhibitors (± ovarian suppression) plus 3-year abemaciclib (100mg bid) without chemotherapy.
treatment of physician's choice including whether to receive chemotherapy, chemotherapy regimen and endocrine therapy regimen.
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Arm 1# endocrine drug plus 3-year abemaciclib without chemotherapy Arm 2# treatment of physician's choice
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Invasive disease free survival | 5 year |
Secondary
| Measure | Time frame |
|---|---|
| disease free survival | 5 year |
| distant disease free survival | 5 year |
| overall survival | 5 year |
| Time Frame: 5 years] 5. adverse effects adverse effects | 5 year |
Countries
China
Contacts
Primary ContactZhimin Shao, MD, PhD
Backup ContactYin Liu, MD
Outcome results
None listed