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A Study for the Neoadjuvant Treatment of Breast Cancer
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Summary
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.
Official title: A Prospective, Open-label Study to Evaluate Injectable Albumin-bound Paclitaxel Versus Docetaxel for the Neoadjuvant Treatment of Breast Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1576
Start Date
2022-07-10
Completion Date
2027-12-20
Last Updated
2022-07-01
Healthy Volunteers
No
Conditions
Interventions
Docetaxel
75 mg/m2, d1, q3w,6 cycles
Carboplatin
AUC 6, d1, q3w ,6 cycles
Trastuzumab
starting dose 8 mg/kg, maintenance dose 6 mg/kg, d1, q3w ,6 cycles
Pertuzumab
starting dose of 840 mg, maintenance dose of 420 mg, d1, q3w,6 cycles
Nab paclitaxel
220 mg/m2, d1, q3w,6 cycles
Epirubicin
90 mg/m2,d1, q3w × 4 cycles,followed by docetaxel
Cyclophosphamide
600 mg/m2, d1, q3w ,4 cycles,followed by docetaxel
Docetaxel
100 mg/m2, d1, q3w × 4 cycles
Epirubicin
90 mg/m2,d1, q2w × 4 cycles,followed by nab-paclitaxel
Cyclophosphamide
600 mg/m2, d1, q2w × 4 cycles followed by nab-paclitaxel
Nab paclitaxel
125 mg/m2, d1,8,15, q3w× 4 cycles
Locations (1)
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China