A Study for the Adjuvant Treatment of Breast Cancer
A Prospective, Open-label, Non-inferiority Study to Evaluate Injectable Albumin-bound Paclitaxel Versus Docetaxel for the Adjuvant Treatment of Breast Cancer
Second Affiliated Hospital, School of Medicine, Zhejiang University
2,413 participants
Jul 10, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
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Interventions
75 mg/m2, d1, q3w,6 cycles
AUC 6, d1, q3w,6 cycles
starting dose 8 mg/kg, maintenance dose 6 mg/kg, d1, q3w,6 cycles
starting dose of 840 mg, maintenance dose of 420 mg, d1, q3w ,6 cycles
220 mg/m2, d1, q3w,6 cycles
90 mg/m2, d1, q3w ,4 cycles ,followed by docetaxel
600 mg/m2, d1, q3w × 4 cycles followed by docetaxel
100 mg/m2, d1, q3w × 4 cycles
90 mg/m2,d1, q2w × 4 cycles followed by nab-paclitaxel
600 mg/m2, d1, q2w × 4 cycles followed by nab-paclitaxel
125 mg/m2, d1,8,15, q3w× 4 cycles
600 mg/m2, d1, q3w × 6 cycles
Locations(1)
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NCT05420467