Breast cancer
Conditions
Interventions
Experimental group:Eribulin plus Tucidinostat
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age 18-75 years; 2. The score of (ECOG) physical condition is = 2; 3. Local advanced or metastatic female breast cancer patients who are pathologically confirmed as HER2 negative are not suitable for radical surgery or radiotherapy; 4. Subjects with local recurrence or metastatic breast cancer who have received at least two and at most five chemotherapy schemes (at least two of which are used to treat local recurrence or metastatic diseases) before this treatment scheme; 5. Patients with ER/PR+have received endocrine therapy at least twice; 6. According to RECIST 1.1, at least one measurable lesion exists; 7. Expected life = 3 months; 8.ANC = 1.5 × 10^9/L,PLT =90 × 10^9/L,Hb = 90 g/L; TBIL=1.5ULNALT/AST=2.5 × ULN (ALT/AST = 5 in subjects with liver metastasis × ULN); BUN/Cr=1.5 × ULN 9) LVEF = 50%, and QTc = 470 ms; 9. Participants must be willing and able to follow the protocol during the study.
Exclusion criteria
Exclusion criteria: 1.Patients who have had prior Eribulin therapy(neoadjuvant or adjuvant therapy)within 1 year of study entry; 2.Any previous treatment with Eribulin was ineffective; 3.Any previous treatment with HDAC inhibitor; 4.Participated in other drug clinical trials within 4 weeks before admission; 5.Patients with CNS metastasis; 6.Patients must have recovered to baseline or = Grade 1 from any effects of any previous therapy to study entry; 7.Active HIV, hepatitis B or hepatitis C; 8.Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial; 9.Patients with severe cardiovascular disease; 10.Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting drug use and absorption; 11.Researchers believe that patients are unsuitable for any other situation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RP2D;PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;MTD; | — |
Countries
China
Contacts
Public ContactMin Yan
The affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Outcome results
None listed