TA(E)C-GP Versus A(E)C-T for the High Risk TNBC Patients and Validation of the mRNA-lncRNA Signature

• Status: Unknown status
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to compare the efficacy and safety between docetaxel combined with doxorubicin (epirubicin) and cyclophosphamide followed by gemcitabine combined with cisplatin and doxorubicin (epirubicin) combined with cyclophosphamide followed by docetaxel for high risk triple negative breast cancer predicted by the mRNA-lncRNA integrated signature and validation the efficacy of the signature.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Cisplatin; Cyclophosphamide; Docetaxel; Doxorubicin; Epirubicin; Gemcitabine; Liposomal doxorubicin

Criteria

Inclusion Criteria:

1. Age: 18-65 years old

2. Expected survival > 12 months

3. Baseline Eastern Cooperative Oncology Group Performance Status rating 0-1

4. Naïve to chemotherapy or hormonal treatments

5. Pathology confirmed invasive ductal carcinoma of breast

6. Triple negative breast cancer confirmed by pathology

7. No concurrent malignancy (except controlled cervical carcinoma in situ or basal cell carcinoma of skin)

8. No advanced metastasis or metastasis involving brain or liver

9. Adequate bone marrow function, blood routine examination shows neutrophil count ≥ 1.5x109/L, hemoglobin level ≥ 100 g/L, Platelets ≥ 100 x 109/L

10. Adequate liver and kidney function, serum aminotransferase (AST) ≤ 60 Unit/L, serum total bilirubin ≤ 2.5 times Upper Limit of Normal, serum creatinine ≤110μmol/L, urea nitrogen ≤7.1mmol/L

11. No coagulation abnormality

12. Normal heart function, with normal ECG and left ventricular ejection fraction ≥ 55%

13. Women of childbearing age agree to take reliable contraceptive measures during clinical trials, and negative serum or urine pregnancy test within 7 days prior to administration

14. No coagulation abnormality

15. Sign the informed consent statement and voluntarily receive follow-ups, treatments, laboratory tests and other research procedures according to protocol.

Exclusion Criteria:

1. Previous regional or systemic treatment for breast cancer (include but not limited to chemotherapy, radiotherapy, targeted therapy, other clinical trials)

2. Inflammatory breast cancer, bilateral breast cancer or breast cancer already with distant metastasis

3. Complicated with uncontrolled lung disease, severe infection, active peptic ulcer, blood clotting disorders, severe uncontrolled diabetes, connective tissue disorders or bone marrow suppression, and intolerance to neoadjuvant therapy or related treatment

4. Peripheral neuropathy >1 degree caused by any reason

5. History of congestive heart failure, uncontrolled or symptomatic angina, arrhythmias or history of myocardial infarction, refractory hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg);

6. Breast cancer during lactation or pregnancy

7. Mental illness or incompliance to treatment caused by other reasons

8. Known history of severe hypersusceptibility to any agents used in the treatment protocol

9. Patients received major surgery or suffered from severe trauma within 2 months of first administration

10. Currently enroll or recently used (30 days within enrollment) other agent under research or involved in other trial

11. Known to be infected with human immunodeficiency virus (HIV)

12. Other circumstances considered to be inappropriate to be enrolled by researchers