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Clinical Trial 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 However, comparative studies between paclitaxel and docetaxel are still rare, In our 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.


Clinical Trial Description

Neoadjuvant chemotherapy refers to systemic chemotherapy as the first step for treating breast cancer patients before planned local treatment like surgery for those without distant metastasis. It is reported that preoperative neoadjuvant chemotherapy can facilitate breast conservation, render inoperable tumors operable and provide important prognostic information at an individual patient level based on response to therapy. The Robidoux team and Shimada's team respectively performed albumin-bound paclitaxel followed by 5-fluorouracil/epirubicin/ cyclophosphamide (nab-P-FEC) and nab-paclitaxel followed by epirubicin combined with cyclophosphamide (nab-P-EC) regimen for a single-arm study of neoadjuvant therapy in breast cancer, respectively. The results of both studies confirmed the efficacy of albumin-bound paclitaxel in neoadjuvant therapy and was well tolerated when combined with sequential chemotherapy with anthracyclines .[1-2] The GBG69 study was the first to compare the efficacy and safety of nab-paclitaxel (nab-P) and solvent-based paclitaxel followed by EC in the neoadjuvant treatment of breast cancer. The results showed that the pCR rate in the nab-P group was significantly higher than that in the solvent paclitaxel group (38% vs 29% p<0.001). Long-term follow-up results showed that after 4 years, iDFS was also significantly improved in nab-P-treated patients compared with solvent paclitaxel (84.0% vs 76.3%; HR, 0.66; 95% CI, 0.51-0.86; P = 0.0023). [3-4] Takashi et al conducted a randomized phase II study comparing docetaxel and albumin paclitaxel in neoadjuvant chemotherapy for HER2-negative early-stage breast cancer. The results showed a slightly higher pCR rate in the nab-P group (docetaxel: 12%; nab-P: 17%). In the Ki67>20% subgroup, the pCR rates were 16% (docetaxel) vs 24% (nab-P) respectively. demonstrating that albumin-bound paclitaxel (nab-P) appears to demonstrate greater efficacy in breast cancer compared to docetaxel [5]. However, comparative studies between paclitaxel and docetaxel However, comparative studies between paclitaxel and docetaxel are still rare, In our 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05420454
Study type Interventional
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Yiding CHEN
Phone 13605719519
Email [email protected]
Status Recruiting
Phase Phase 4
Start date June 10, 2022
Completion date December 20, 2027

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