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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05207514

Enrollment

Registered

2022-01-26

Start date

2022-03-31

Completion date

2024-05-09

Last updated

2024-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

DRUGNanoxel M

75 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide

DRUGTaxotere

75 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide

DRUGDoxorubicin

60 mg/m2, intravenously every 3 weeks for 4 cycles. Given as first treatment with cyclophosphamide

DRUGCyclophosphamide

600 mg/m2, intravenously every 3 weeks for 4 cycles. Given as first treatment with doxorubicin.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026