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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05207514
• Other study ID #: DPMBC301
• Status: Terminated
• Phase: Phase 3
• Start date: March 31, 2022
• Est. completion date: May 9, 2024

Study information

• Verified date: May 2023
• Source: Samyang Biopharmaceuticals Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: May 9, 2024
• Est. primary completion date: February 7, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Sevrance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samyang Biopharmaceuticals Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0	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.	at the time of definitive surgery