Actively Recruiting
EC-THP Versus TCbHP in HER2-positive Lymph Node Positive Early Breast Cancer
Led by Fudan University · Updated on 2023-06-27
1406
Participants Needed
1
Research Sites
420 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
compare the efficacy and safety of TCbHP and EC-THP regimen in HER2-positive breast cancer patients
CONDITIONS
Official Title
EC-THP Versus TCbHP in HER2-positive Lymph Node Positive Early Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 70 years
- ECOG performance status of 0 or 1
- Unilateral invasive breast cancer confirmed by histology
- No visible tumor remains after surgery
- Pathologically confirmed HER2-positive early breast cancer (HER2 3+ or FISH/CISH positive)
- Postoperative pathological stage pT1-4N1-3M0
- No prior neoadjuvant chemotherapy
- Surgery to randomization interval no more than 8 weeks and no adjuvant therapy received after surgery
- No peripheral neuropathy
- Good postoperative recovery with at least one week interval after surgery
- Normal major organ function including blood counts, liver and kidney function within specified limits
- Use of contraception during treatment for women of reproductive age
- Cardiac function with left ventricular ejection fraction (LVEF) greater than 50%
- Voluntary participation with signed informed consent and ability to comply with follow-up
You will not qualify if you...
- Bilateral breast cancer or carcinoma in situ (DCIS/LCIS)
- Prior chemotherapy for advanced disease
- Cancer spread beyond primary site (metastasis)
- Tumors larger than T4a or with skin invasion, fixation, or inflammatory breast cancer
- Suspicion of malignancy in the opposite breast requiring biopsy but not confirmed
- Prior neoadjuvant therapy including chemotherapy, radiotherapy, or endocrine therapy
- Other malignant tumors within the past 5 years except certain skin or cervical cancers
- Participation in other clinical trials
- Severe systemic disease or uncontrolled infection
- Cardiac function with LVEF less than 50%
- Severe cardiovascular or cerebrovascular disease within 6 months before randomization
- Known allergy to study drugs
- Women of childbearing age refusing contraception during treatment and for 8 weeks after
- Pregnant or breastfeeding women
- Positive pregnancy test after joining the trial
- Mental illness, cognitive impairment, or inability to understand or comply with the trial protocol
- Lack of personal freedom or independent capacity for civil conduct
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center Shanghai, China, 200032
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
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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