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

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

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Nanoxel M; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Taxotere

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Sevrance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nanoxel M; AC(Doxorubicin, Cyclophosphamide) followed by Nanoxel M	Drug: Nanoxel M; 75 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide; Other Names: polysorbate 80, ethanol free docetaxel; Drug: Doxorubicin; 60 mg/m2, intravenously every 3 weeks for 4 cycles. Given as first treatment with cyclophosphamide; Drug: Cyclophosphamide; 600 mg/m2, intravenously every 3 weeks for 4 cycles. Given as first treatment with doxorubicin.
Active Comparator: Taxotere; AC(Doxorubicin, Cyclophosphamide) followed by Taxotere	Drug: Doxorubicin; 60 mg/m2, intravenously every 3 weeks for 4 cycles. Given as first treatment with cyclophosphamide; Drug: Cyclophosphamide; 600 mg/m2, intravenously every 3 weeks for 4 cycles. Given as first treatment with doxorubicin.; Drug: Taxotere; 75 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide; Other Names: docetaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of ypT0 Subjects	H & E staining of tissues obtained from breast was defined as the absence of invasive and in situ cancer, and the proportion of subjects was determined.	at the time of definitive surgery
Percentage of ypT0/is Subjects	H & E staining of tissues obtained from breast was defined as the absence of invasive cancer, and the proportion of subjects was determined.	at the time of definitive surgery
Percentage of ypT0 ypN0 Subjects	H & E staining of tissues obtained from breast and axillary lymph nodes was defined as the absence of invasive and in situ cancer, and the proportion of subjects was determined.	at the time of definitive surgery
Response rate	Response rate confirmed by CT or MRI during the study (by RECIST 1.1)	at the time of definitive surgery
Percentage of Subjects with Breast Conservation Surgery	Percentage of Subjects with Breast Conservation Surgery	at the time of definitive surgery
Percentage of subjects by RCB (Residual cancer burden) grade after chemotherapy before surgery	tissue obtained from breat and axillary lymph node were evaluated to determine the proportion of subjects in each grade (RCB 0, RCB-I, RCB-II, RCB III)	at the time of definitive surgery

Collaborators and Investigators

• Sponsor: Samyang Biopharmaceuticals Corporation
• Investigators: Principal Investigator: Joohyuk Sohn, M.D.,Ph.D., Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2022
• Primary Completion (Actual): February 7, 2024
• Study Completion (Actual): May 9, 2024

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Ethanol; Docetaxel; Cyclophosphamide; Doxorubicin
• Other Study ID Numbers: DPMBC301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No