Actively Recruiting
A Study for the Adjuvant Treatment of Breast Cancer
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2022-07-01
2413
Participants Needed
1
Research Sites
284 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Studies on postoperative adjuvant albumin paclitaxel in domestic breast cancer patients are less reported, especially in large samples, and more studies focus more on the safety and tolerability of albumin paclitaxel use. Head-to-head studies of white violet and docetaxel are not supported by data at this time, but some studies have shown that docetaxel-induced long-term Other adverse effects such as myelosuppression, hepatotoxicity and hypersensitivity reactions can have a serious impact on quality of life. Therefore, this study aims to analyse the efficacy and safety of albumin paclitaxel and docetaxel in the adjuvant treatment of breast cancer in a large randomized controlled trial, and to further analyse the efficacy and safety of albumin paclitaxel in combination with chemotherapy for postoperative breast cancer in different subtypes of breast cancer patients, in order to obtain more realistic data and provide new treatment options for breast cancer patients.
CONDITIONS
Official Title
A Study for the Adjuvant Treatment of Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 years or older
- Diagnosed with stage I to III breast cancer without distant metastasis (M0)
- Known hormone receptor status (ER, PR), HER2 status, and Ki67 expression levels
- Specific breast cancer subtypes: triple-negative with tumor >2cm or lymph node involvement, luminal with lymph node involvement, or HER2-positive regardless of ER/PR status
- Underwent breast cancer surgery with systemic lymph node dissection, with complete tumor removal (R0 resection)
- Start of adjuvant therapy within 21 days after surgery
- ECOG physical fitness score of 0-1 and expected survival over 6 months
- No prior treatment with paclitaxel regimen
- No concurrent endocrine therapy or radiotherapy during adjuvant chemotherapy
- Women of childbearing potential must use reliable contraception and have negative pregnancy test before enrollment
- Normal cardiac function confirmed by ECG and echocardiography within 3 months before randomization
- Liver and kidney function within specified limits
- Adequate bone marrow function
- Ability to comply with outpatient treatment, monitoring, and clinical visits
- Ability to understand, agree, and sign informed consent
You will not qualify if you...
- Advanced or inoperable breast cancer with distant metastasis
- Other malignant tumors within past 5 years except certain skin and cervical cancers
- Pregnant or breastfeeding women, or unwilling/unable to use contraception
- Unknown ER/PR, HER2, or Ki67 status
- Central nervous system metastases or peripheral neuropathy above grade 1
- Severe cardiovascular disease or poor heart function
- Uncontrolled hypertension
- Major surgery, severe injury, fracture, or ulcer within 4 weeks before enrollment
- Severe myelosuppression at screening
- Severe liver or renal dysfunction at screening
- Recent arterial or venous thrombosis within 6 months before randomization
- Hypersensitivity to study drugs
- Psychiatric disorders
- Participation in another clinical study within 4 weeks before enrollment
- Other conditions judged by investigator to affect study participation or results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
Y
Yiding CHEN
CONTACT
H
Huihui CHEN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here