Actively Recruiting
Chemotherapy Omission in ER+/HER2- Breast Cancer With 1-3 Positive Lymph Nodes Receiving Extended Adjuvant Abemaciclib
Led by Fudan University · Updated on 2024-04-10
1900
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Chemotherapy Omission in ER+/HER2- Breast Cancer With 1-3 Positive Lymph Nodes Receiving Extended Adjuvant Abemaciclib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 80 years old
- Diagnosed with localized invasive breast carcinoma with 1-3 positive lymph nodes, T1-T2, confirmed as ER+/HER2- by histopathology after early breast cancer surgery
- Estrogen receptor expression of 50% or more
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function including bone marrow, liver, and kidney according to defined laboratory values
- Provided voluntary informed consent and agreed to follow-up with good compliance
You will not qualify if you...
- Previous neoadjuvant therapy including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy
- Bilateral breast cancer
- History of other malignancies except adequately treated basal cell carcinoma or cervical carcinoma in situ
- Metastatic (Stage 4) breast cancer
- Any tumor lesion of stage T3 or greater
- Pregnancy, breastfeeding, or inability to use effective contraception if of childbearing potential
- Participation in other clinical trials at the same time
- Severe organ dysfunction or cardiac issues including left ventricular ejection fraction below 50%, recent severe cardiovascular disease, uncontrolled hypertension, poorly controlled diabetes, or severe hypertension
- Severe or uncontrolled infection
- Judged unsuitable for the study by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
Zhimin Cancer Shao
Shanghai, China, 200032
Actively Recruiting
Research Team
Z
Zhimin Shao, MD, PhD
CONTACT
Y
Yin Liu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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