Actively Recruiting
A Study for the Neoadjuvant Treatment of Breast Cancer
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2022-07-01
1576
Participants Needed
1
Research Sites
284 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Due to the unique advantages of albumin-bound paclitaxel, several studies in China and abroad have tried to use albumin-bound paclitaxel for neoadjuvant treatment of breast cancer up to now. However, comparative studies between paclitaxel and docetaxel are still rare, In this study, a prospective, randomized, open-label, multi-center clinical study was conducted to analyse the efficacy and safety of albumin-bound paclitaxel and docetaxel in the neoadjuvant treatment of breast cancer, 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 Neoadjuvant Treatment of Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 618 years
- Unilateral primary invasive breast cancer confirmed by histology
- Tumor larger than 2 cm or clinical/pathological evidence of lymph node metastasis
- Known hormone receptor (ER, PR) and HER2 status with Ki67 expression levels
- Breast cancer subtype: triple-negative, luminal with lymph node metastasis, or HER2-positive
- Need for neoadjuvant chemotherapy as judged by investigator
- ECOG physical fitness score of 0-1
- No prior treatment for breast cancer before enrollment
- Normal cardiac function confirmed by ECG and echocardiography within 3 months, with LVEF 655%
- Adequate liver and kidney function
- Adequate bone marrow function
- Ability to comply with outpatient treatment, lab 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
- Bilateral invasive breast cancer
- Other malignant tumors in past 5 years except certain cured skin or cervical cancers
- Pregnant or breastfeeding, or unwilling/unable to use effective contraception
- Unknown molecular status of ER/PR, HER2, or Ki67
- CNS metastases or peripheral neuropathy above grade 1
- Surgical axillary staging within 6 months prior to study entry
- Prior radiotherapy, chemotherapy, biotherapy, or endocrine therapy for current breast cancer
- Severe myelosuppression at screening
- Severe liver dysfunction (Child's Class III) or renal dysfunction at screening
- Other severe concomitant diseases endangering patient safety or study completion
- Hypersensitivity to study drugs
- Psychiatric disorders
- Participation in another clinical study with recent dosing
- Other investigator-judged conditions unsuitable for study inclusion
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
4
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