Eribulin Plus Tucidinostat in the Treatment of HER2-negative Advanced Breast Cancer

• Status: Not yet recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

Study to Evaluate the Safety and Efficacy of Eribulin plus Tucidinostat in the Treatment of HER2-negative Advanced Breast Cancer

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henan Cancer Hospital

Criteria

Inclusion Criteria:

1. Age 18-75 years.

2. ECOG performance status≤2.

3. Histologically or cytologically-confirmed HER2 negative breast cancer that is metastatic or unresectable.

4. Patients must have received at least 2 lines of chemotherapy in the Local recurrent or metastatic setting.Patients must have received no more than 5 lines of chemotherapy for breast cancer.

5. Patients with estrogen and/or progesterone receptor-positive disease must have received and progressed on at least 2 endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy.

6. at least one measurable lesion according to RECIST 1.1

7. life expectancy is not less than 3 months

8. ANC ≥ 1.5×10^9/L, PLT ≥90×10^9/L,Hb ≥ 90 g/L;TBIL≤1.5ULN ALT and AST≤2.5×ULN（ALT and AST≤5×ULN if liver metastasis）;BUN and Cr≤1.5×ULN 9）LVEF ≥ 50% and QTc≤470 ms.

9. Participants must be willing and able to comply with the protocol for the duration of the study

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.