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

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samyang Biopharmaceuticals Corporation
• Treatments: Cyclophosphamide; Docetaxel; Doxorubicin; Ethanol

Criteria

Inclusion Criteria:

1. Patients who voluntarily decide to participate and give written consent after hearing and understanding detailed explanations of this clinical trial

2. Female adult subjects 19 years of age or older

3. Patients who were diagnosed with primary breast cancer by core biopsy

4. 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 +

5. Patinets whose TNM stage confirmed by CT or MRI (T2-T3, anyN, M0 or T1-3, N1-3, M0)

6. Patients who show adequate blood, renal, and liver functions at screening as follows

• ANC ≥ 2.0 X 109/L

• Platelets ≥ 100 X 109/L

• Hemoglobin ≥ 10 g/dL (≥ 6.2 mmol/L)

• Total bilirubin < 1.5 X UNL

• AST 및 ALT ≤ 2.5 X UNL

• ALP ≤ 2.5 X UNL

• Creatinine < 1.5 X UNL (or creatinine clearance ≥ 60ml/min)

7. Patients whose ECOG performance scores are 0-1

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

6. Hypertensive Patients who have systolic blood pressure ≥ 160mmHg or diastolic blood pressure ≥ 100mmHg

7. Patients who have received chemotherapy prior to participation in this clinical trial or who have received radiation therapy for breast cancer

8. 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

9. Patients who have active infection at the screening visit

10. Patients who have history of grade 2 or higher peripheral motor neuropathy or peripheral sensory neuropathy by CTCAE V5.0

11. Pregnant or lactating women

12. 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..)

13. Patients who have a history of malignant tumors except breast cancer within 5 years of screening visit

14. Patients who have heart failure (NYHA class I or higher), arrhythmias requiring treatment, and clinically significant heart valve disease

15. 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

16. Patients who have history of anaphylaxis to the main or subcomponents of this ingredient

17. Patients requiring the administration of concomitant contraindications during this clinical trial

18. Patients who are contraindicated in the administration of corticosteroids

19. 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)

20. Other, if the investigator judges that he or she is not suitable to participate