Phase Ib clinical study of Decitabine and Paclitaxel combination therapy

An open-labelled, parallel, multiple ascending dose, phase Ib clinical study of Decitabine and Paclitaxel combination therapy in treating patients with metastatic and locally advanced breast cancer

Inclusion Criteria:

1. age ≥ 19 years as female
2. be unable to operate for therapy with HER2 negative breast adenocarcinoma and metastatic breast cancer, one or more chemotherapy
3. according to RECIST ver.1.1, one or more evaluable lesion
4. Eastern cooperative oncology group(ECOG) performance score is o or 1
5. lesion for core biopsy
6. Within 28days of planned first study treatment day, laboratory safety test is satisfied. ANC ≥1500cells/microliter, Platelet count ≥ 100,000 cells/microliter, Hemoglobin≥8.5g/dl, ALT and AST ≤ 2ULN, ALP≤2.5ULN, Serum total bilirubin≤1.25 ULN, PT-INR and aPTT≤1.5ULN, Creatinine≥50ml/min
7. menopause or informed that effective contraception must be used during the entire treatment period of this study and for 6 months after exiting from the study
8. Given signed and dated written informed consent form

Exclusion Criteria:

1. Symptomatic metastasis and Leptomeningeal metastasis
2. Injection of paclitaxel for metastatic breast cancer within 6 months
3. HER2, Positive Breast adenocarcinoma
4. cancertherapy for whole body within 3 weeks
5. radiotherapy for metastatic region within 4 weeks
6. major surgery, open biopsy and trauma within 4 weeks
7. less than 4 weeks post major surgery
8. treatment with consistently systemic corticosteroid or immunosuppressive drug
9. more than 2 grade for peripheral neuropathy
10. Congenital ling QT syndrome or QTc interval > 480 milisecond
11. occur myocardial infartion within 6 months
12. unstable angina pectoris
13. HIV(+) or AIDS
14. HBsAg(+) or HCV(+)
15. treatment bisphosphonate for hypercalcemia
16. except metastatic and locally advanced breast cancer, personal history with malignancy within 5 years
17. hypersensitivity reaction with paclitaxel or Cremophor EL formulation
18. Pregnant or breast feeding
19. be unable or unwilling to abide by the study protocol or to cooperate fully with the investigator or designee