Compare the Efficacy and the Safety of Doxorubicin and Cyclophosphamide Followed by Taxotere Versus Doxorubicin and Cyclophosphamide Nanoxel M as Neoadjuvant Chemotherapy in Breast Cancer
Primary Purpose
Breast Cancer
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Nanoxel M
Taxotere
Doxorubicin
Cyclophosphamide
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients who voluntarily decide to participate and give written consent after hearing and understanding detailed explanations of this clinical trial
- Female adult subjects 19 years of age or older
- Patients who were diagnosed with primary breast cancer by core biopsy
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 +
- Patinets whose TNM stage confirmed by CT or MRI (T2-T3, anyN, M0 or T1-3, N1-3, M0)
Patients who show adequate blood, renal, and liver functions at screening as follows
<Hematology>
- ANC ≥ 2.0 X 109/L
- Platelets ≥ 100 X 109/L
- Hemoglobin ≥ 10 g/dL (≥ 6.2 mmol/L)
<Liver function>
- Total bilirubin < 1.5 X UNL
- AST 및 ALT ≤ 2.5 X UNL
- ALP ≤ 2.5 X UNL
<Renal function>
- Creatinine < 1.5 X UNL (or creatinine clearance ≥ 60ml/min)
- Patients whose ECOG performance scores are 0-1
Exclusion criteria:
- Patients who have distant metastasis
- Patients who have cystitis or urinary obstruction
- Patients who have history of thromboembolism or coagulation disorder
- Patients who have Interstitial lung disease ans liver cirrhosis ( > Child-Pugh class B)
- Patients who have Insulin-Dependent Type II diabete mellitus
- Hypertensive Patients who have systolic blood pressure ≥ 160mmHg or diastolic blood pressure ≥ 100mmHg
- Patients who have received chemotherapy prior to participation in this clinical trial or who have received radiation therapy for breast cancer
- Patients whose medical or mental state judged by the investigator as to be impossible to understand this clinical study and sign the written consent form
- Patients who have active infection at the screening visit
- Patients who have history of grade 2 or higher peripheral motor neuropathy or peripheral sensory neuropathy by CTCAE V5.0
- Pregnant or lactating women
- A woman of childbearing age who does not agree to the use of medically acceptable contraceptive methods (blocking, intrauterine contraceptive devices) during the study (However, those who have a record of menopause before definition (defined as amenorrhea for at least one year) or surgical sterilization are excluded from women of childbearing age..)
- Patients who have a history of malignant tumors except breast cancer within 5 years of screening visit
- Patients who have heart failure (NYHA class I or higher), arrhythmias requiring treatment, and clinically significant heart valve disease
- Patients who have transient cerebral ischemic attack (TIA), myocardial infarction, unstable angina, cerebral infarction, cerebral hemorrhage within 6 months prior to screening or a history of angioplasty or coronary artery bypass surgery
- Patients who have history of anaphylaxis to the main or subcomponents of this ingredient
- Patients requiring the administration of concomitant contraindications during this clinical trial
- Patients who are contraindicated in the administration of corticosteroids
- Patients who have experience of participating in another clinical trial within 3 months to screening (participation is based on the date of final administration of the investigational drug)
- Other, if the investigator judges that he or she is not suitable to participate
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nanoxel M
Taxotere
Arm Description
AC(Doxorubicin, Cyclophosphamide) followed by Nanoxel M
AC(Doxorubicin, Cyclophosphamide) followed by Taxotere
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Response rate
Response rate confirmed by CT or MRI during the study (by RECIST 1.1)
Percentage of Subjects with Breast Conservation Surgery
Percentage of Subjects with Breast Conservation 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)
Full Information
NCT ID
NCT05207514
First Posted
January 7, 2022
Last Updated
January 20, 2022
Sponsor
Samyang Biopharmaceuticals Corporation
1. Study Identification
Unique Protocol Identification Number
NCT05207514
Brief Title
Compare the Efficacy and the Safety of Doxorubicin and Cyclophosphamide Followed by Taxotere Versus Doxorubicin and Cyclophosphamide Nanoxel M as Neoadjuvant Chemotherapy in Breast Cancer
Official Title
Open-label, Randomized, Active-controlled, Multicenter, 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 Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2022 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samyang Biopharmaceuticals Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nanoxel M
Arm Type
Experimental
Arm Description
AC(Doxorubicin, Cyclophosphamide) followed by Nanoxel M
Arm Title
Taxotere
Arm Type
Active Comparator
Arm Description
AC(Doxorubicin, Cyclophosphamide) followed by Taxotere
Intervention Type
Drug
Intervention Name(s)
Nanoxel M
Other Intervention Name(s)
polysorbate 80, ethanol free docetaxel
Intervention Description
75 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Taxotere
Other Intervention Name(s)
docetaxel
Intervention Description
75 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
60 mg/m2, intravenously every 3 weeks for 4 cycles. Given as first treatment with cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
600 mg/m2, intravenously every 3 weeks for 4 cycles. Given as first treatment with doxorubicin.
Primary Outcome Measure Information:
Title
Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0
Description
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.
Time Frame
at the time of definitive surgery
Secondary Outcome Measure Information:
Title
Percentage of ypT0 Subjects
Description
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.
Time Frame
at the time of definitive surgery
Title
Percentage of ypT0/is Subjects
Description
H & E staining of tissues obtained from breast was defined as the absence of invasive cancer, and the proportion of subjects was determined.
Time Frame
at the time of definitive surgery
Title
Percentage of ypT0 ypN0 Subjects
Description
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.
Time Frame
at the time of definitive surgery
Title
Response rate
Description
Response rate confirmed by CT or MRI during the study (by RECIST 1.1)
Time Frame
at the time of definitive surgery
Title
Percentage of Subjects with Breast Conservation Surgery
Description
Percentage of Subjects with Breast Conservation Surgery
Time Frame
at the time of definitive surgery
Title
Percentage of subjects by RCB (Residual cancer burden) grade after chemotherapy before surgery
Description
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)
Time Frame
at the time of definitive surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who voluntarily decide to participate and give written consent after hearing and understanding detailed explanations of this clinical trial
Female adult subjects 19 years of age or older
Patients who were diagnosed with primary breast cancer by core biopsy
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 +
Patinets whose TNM stage confirmed by CT or MRI (T2-T3, anyN, M0 or T1-3, N1-3, M0)
Patients who show adequate blood, renal, and liver functions at screening as follows
<Hematology>
ANC ≥ 2.0 X 109/L
Platelets ≥ 100 X 109/L
Hemoglobin ≥ 10 g/dL (≥ 6.2 mmol/L)
<Liver function>
Total bilirubin < 1.5 X UNL
AST 및 ALT ≤ 2.5 X UNL
ALP ≤ 2.5 X UNL
<Renal function>
Creatinine < 1.5 X UNL (or creatinine clearance ≥ 60ml/min)
Patients whose ECOG performance scores are 0-1
Exclusion criteria:
Patients who have distant metastasis
Patients who have cystitis or urinary obstruction
Patients who have history of thromboembolism or coagulation disorder
Patients who have Interstitial lung disease ans liver cirrhosis ( > Child-Pugh class B)
Patients who have Insulin-Dependent Type II diabete mellitus
Hypertensive Patients who have systolic blood pressure ≥ 160mmHg or diastolic blood pressure ≥ 100mmHg
Patients who have received chemotherapy prior to participation in this clinical trial or who have received radiation therapy for breast cancer
Patients whose medical or mental state judged by the investigator as to be impossible to understand this clinical study and sign the written consent form
Patients who have active infection at the screening visit
Patients who have history of grade 2 or higher peripheral motor neuropathy or peripheral sensory neuropathy by CTCAE V5.0
Pregnant or lactating women
A woman of childbearing age who does not agree to the use of medically acceptable contraceptive methods (blocking, intrauterine contraceptive devices) during the study (However, those who have a record of menopause before definition (defined as amenorrhea for at least one year) or surgical sterilization are excluded from women of childbearing age..)
Patients who have a history of malignant tumors except breast cancer within 5 years of screening visit
Patients who have heart failure (NYHA class I or higher), arrhythmias requiring treatment, and clinically significant heart valve disease
Patients who have transient cerebral ischemic attack (TIA), myocardial infarction, unstable angina, cerebral infarction, cerebral hemorrhage within 6 months prior to screening or a history of angioplasty or coronary artery bypass surgery
Patients who have history of anaphylaxis to the main or subcomponents of this ingredient
Patients requiring the administration of concomitant contraindications during this clinical trial
Patients who are contraindicated in the administration of corticosteroids
Patients who have experience of participating in another clinical trial within 3 months to screening (participation is based on the date of final administration of the investigational drug)
Other, if the investigator judges that he or she is not suitable to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miryung Jin
Phone
+82-2-2157-9842
Email
miryung.jin@samyang.com
First Name & Middle Initial & Last Name or Official Title & Degree
Joohyuk Sohn
Phone
+82-2-2228-8135
Email
oncosohn@yumc.yonsei.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joohyuk Sohn
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Compare the Efficacy and the Safety of Doxorubicin and Cyclophosphamide Followed by Taxotere Versus Doxorubicin and Cyclophosphamide Nanoxel M as Neoadjuvant Chemotherapy in Breast Cancer
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