Status:
TERMINATED
Compare the Efficacy and the Safety of Taxotere and Nanoxel M as Neoadjuvant Chemotherapy in Breast Cancer
Lead Sponsor:
Samyang Biopharmaceuticals Corporation
Conditions:
Breast Cancer
Eligibility:
FEMALE
19+ years
Phase:
PHASE3
Brief 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...
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.
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients who were diagnosed with primary breast cancer by core biopsy
- Patients who have been identified as HER2 negative in the tissue obtained through core needle biopsy and have confirmed the positive / negative status of ER (Estrogen receptor) and Progesterone receptor (PR)
- HER2 positive is defined as IHC 3+ or FISH +
- Patinets whose TNM stage confirmed by CT or MRI (T2-T3, anyN, M0 or T1-3, N1-3, M0)
- Exclusion criteria:
- Patients who have distant metastasis
- Patients who have cystitis or urinary obstruction
- Patients who have history of thromboembolism or coagulation disorder
- Patients who have Interstitial lung disease ans liver cirrhosis ( \> Child-Pugh class B)
- Patients who have Insulin-Dependent Type II diabete mellitus
Exclusion
Key Trial Info
Start Date :
March 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2024
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT05207514
Start Date
March 31 2022
End Date
May 9 2024
Last Update
May 17 2024
Active Locations (1)
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1
Sevrance Hospital
Seoul, South Korea