NCT05207514

Compare the Efficacy and the Safety of Taxotere and Nanoxel M as Neoadjuvant Chemotherapy in Breast Cancer

Open-label, Randomized, Active-controlled, Multicenter, Phase III Clinical Trial to Compare the Efficacy and the Safety of Taxotere and Nanoxel M as Neoadjuvant Chemotherapy in Breast Cancer

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Samyang Biopharmaceuticals Corporation · Industry
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Phase III Clinical Trial to Compare the Efficacy and the Safety of AC(Doxorubicin, Cyclophosphamide) Followed by 4 Cycles Taxotere Versus AC(Doxorubicin, Cyclophosphamide) Followed by 4 Cycles Nanoxel M as Neoadjuvant Chemotherapy in Patients With Breast Cancer

Detailed description

The purpose of this study is to evaluate efficacy and safety of AC followed by Taxotere versus AC followed by Nanoxel M as neoadjuvant chemotherapy in breast caner patients.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Nanoxel M	75 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide
DRUG	Taxotere	75 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide
DRUG	Doxorubicin	60 mg/m2, intravenously every 3 weeks for 4 cycles. Given as first treatment with cyclophosphamide
DRUG	Cyclophosphamide	600 mg/m2, intravenously every 3 weeks for 4 cycles. Given as first treatment with doxorubicin.

Timeline

• Start date: 2022-03-31
• Primary completion: 2024-02-07
• Completion: 2024-05-09
• First posted: 2022-01-26
• Last updated: 2024-05-17

Locations

1 site across 1 country: South Korea