Actively Recruiting
Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With ER+ & HER2- Breast Cancer
Led by Peking University · Updated on 2021-11-29
234
Participants Needed
1
Research Sites
596 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study proposes to prove that the efficacy of adjuvant endocrine therapy for the premenopausal HR positive breast cancer patients is non-inferiority to adjuvant chemotherapy assessed by ultrasound response rate.
CONDITIONS
Official Title
Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With ER+ & HER2- Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 35 to 55 years, premenopausal as judged by researchers at recruitment
- Histologically confirmed primary invasive breast cancer
- Stage T2N0M0 with tumor size greater than 2cm and negative sentinel lymph node biopsy
- Breast conserving surgery not feasible or may affect breast appearance
- Hormone receptor-positive (ER or PR positive, >50% cells by IHC) and HER2 negative breast cancer
- No previous treatment for primary breast cancer
- No other tumors or unstable complications or uncontrolled infections
- No contraindications for third generation aromatase inhibitors, LHRHa, or chemotherapy
- Voluntary participation with signed informed consent
You will not qualify if you...
- Metastatic disease diagnosed pathologically or radiologically
- History of other tumors
- Contraindications for third generation aromatase inhibitors, LHRHa, or chemotherapy
- Serious heart, cerebral vessel disease, liver or kidney dysfunction, blood disorders, or other conditions making chemotherapy unsuitable
- Contraindications for surgery such as anesthesia issues, large lesions, T4 stage, or lymph node positivity
- Psychological, mental, social, or geographic problems preventing participation
- Participation in other anti-tumor treatments or clinical trials
- Refusal to participate in the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital Breast Center
Beijing, China
Actively Recruiting
Research Team
T
Tao Ouyang, 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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