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

Phase 3

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: Nanoxel M; Drug: Taxotere; Drug: Doxorubicin; Drug: Cyclophosphamide

• Registration Number: NCT05207514
• Lead Sponsor: Samyang Biopharmaceuticals Corporation

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 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.

Study Timeline

• Study First Submitted: 2022-01-07
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-01-26
• Study Start: 2022-03-31
• Status Verified: 2023-05
• Primary Completion: 2024-02-07
• Study Completion: 2024-05-09
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 26

Inclusion Criteria

1. Patients who were diagnosed with primary breast cancer by core biopsy

2. 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 +

3. Patinets whose TNM stage confirmed by CT or MRI (T2-T3, anyN, M0 or T1-3, N1-3, M0)

Exclusion criteria:

1. Patients who have distant metastasis
2. Patients who have cystitis or urinary obstruction
3. Patients who have history of thromboembolism or coagulation disorder
4. Patients who have Interstitial lung disease ans liver cirrhosis ( > Child-Pugh class B)
5. Patients who have Insulin-Dependent Type II diabete mellitus

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nanoxel M	Nanoxel M	AC(Doxorubicin, Cyclophosphamide) followed by Nanoxel M
Taxotere	Taxotere	AC(Doxorubicin, Cyclophosphamide) followed by Taxotere
Nanoxel M	Doxorubicin	AC(Doxorubicin, Cyclophosphamide) followed by Nanoxel M
Nanoxel M	Cyclophosphamide	AC(Doxorubicin, Cyclophosphamide) followed by Nanoxel M
Taxotere	Doxorubicin	AC(Doxorubicin, Cyclophosphamide) followed by Taxotere
Taxotere	Cyclophosphamide	AC(Doxorubicin, Cyclophosphamide) followed by Taxotere

Primary Outcome Measures

Name	Time	Method
Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0	at the time of definitive surgery	H \& E staining of tissues obtained from breast and axillary lymph nodes was defined as the absence of invasive cancer, and the proportion of subjects was determined.

Trial Locations

Locations (1)

Sevrance Hospital; 🇰🇷 Seoul, Korea, Republic of