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

Samyang Biopharmaceuticals Corporation

Status and phase: Terminated; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Taxotere; Drug: Nanoxel M

Study type: Interventional

Funder types: Industry

Identifiers

NCT05207514

DPMBC301

Details and patient eligibility

About

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

Full 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.

Enrollment: 26 patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

26 participants in 2 patient groups

Nanoxel M

Experimental group

Description:

AC(Doxorubicin, Cyclophosphamide) followed by Nanoxel M

Treatment:

Drug: Nanoxel M

Drug: Cyclophosphamide

Drug: Doxorubicin

Taxotere

Active Comparator group

Description:

AC(Doxorubicin, Cyclophosphamide) followed by Taxotere

Treatment:

Drug: Cyclophosphamide

Drug: Doxorubicin

Drug: Taxotere