Tucidinostat and Fulvestrant in Hormone-receptor Positive Advanced Breast Cancer
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Female patients aged 18-75 years (including cutoff value);
- The disease condition is inoperable, recurrent breast cancer, or metastatic breast cancer;
- Histological or cytological confirmation of hormone receptor-positive [estrogen receptor (ER) positive and progesterone receptors (PgR) positive or negative] breast cancer;
- At least one measurable lesion according to RECIST 1.1;
- Prior treatment: have not received systemic chemotherapy for recurrent or metastatic breast cancer;
- Eastern Cooperative Oncology Group Performance Status of 0-1;
Adequate function of major organs meets the following requirements):
Absolute Neutrophils count≥ 1.5×10^9/L; Platelets count≥ 90×10^9/L; Hemoglobin ≥ 90g/L; Total bilirubin≤ 1.5 × the upper limit of normal (ULN); ALT and AST ≤ 2.5 × ULN; BUN and Cr ≤ 1.5 × ULN; Left ventricular ejection fraction (LVEF) ≥ 50%; QTcF(Fridericia correction) ≤ 470 ms; International normalized ratio(INR)≤1.5 × ULN; activated partial thromboplastin time(APTT) ≤ 1.5 × ULN;
- Life expectancy ≥ 3 months;
- Have signed informed consent.
Exclusion Criteria:
- Patients have untreated central nervous system (CNS) metastases;
- Patients with no measurable lesion according to RECIST 1.1;
- Patients with bilateral breast cancer;
- Patients with human epidermal growth factor receptor-2 (Her-2) positive;
- Recurrent or metastatic disease occurs within 2 years during adjuvant endocrine therapy;
- Patients previously received systemic chemotherapy for recurrent or metastatic breast cancer;
- Patients previously received any HDAC inhibitor or fulvestrant treatment;
- There are ascites, pleural effusion, pericardial effusion with clinical symptoms at baseline, those who need drainage, or those who have undergone drainage of serous effusion within 4 weeks before the first dose;
- Inability to swallow, intestinal obstruction or other factors affecting the administration and absorption of the drug;
- Patients with other invasive malignancies within 5 years or at the same time, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ;
- Patients with a history of allergies to the drug components of this regimen;
- Patients with active HBV and HCV infection; stable hepatitis B after drug treatment (HBV virus copy number is higher than the upper limit of reference value) and cured hepatitis C patients (HCV virus copy number exceeds the lower limit of detection method) can be included;
- Patients with a history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, history of organ transplantation;
- Patients have uncontrolled or significant cardiovascular disease, including: Myocardial infarction (< the last 12 months); Uncontrolled angina (< the last 6 months); Congestive heart failure (< the last 6 months), or Left Ventricular Ejection Fraction (LVEF) < 50% prior to study entry;
- Any mental or cognitive disorder, that would interfere the ability to understand the informed consent document or the operation and compliance of study;
- Any other condition which is inappropriate for the study in the opinion of the investigators.
Sites / Locations
Arms of the Study
Arm 1
Experimental
Tucidinostat + Fulvestrant
Patients receive 30 mg Chidamide twice per week. Fulvestrant 500mg (2 syringes of Fulvestrant 250mg), Fulvestrant 500 mg i.m. every 28 (+/- 3) days plus an additional 500 mg on day 14 (+/-3) of first month only. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.