Overview
The objective of the study is to evaluate the efficacy and safety of chemotherapy plus deferoxamine in metastatic breast cancer whose evaluation is stable disease with a trend of progression.
Description
This is a phase II, single center, prospective, single arm clinical trial. A lot of in vitro and in vivo study demonstrate that deferoxamine can increase anti-tumor effect. The objective of the study is to evaluate the efficacy and safety of chemotherapy plus deferoxamine in metastatic breast cancer whose evaluation is stable disease with a trend of progression after second-line. This study plans to recruit 30 subjects.
Eligibility
Inclusion Criteria:
- Has measurable metastatic triple-negative breast cancer, with at least 1 measurable lesion per RECIST criteria.
- Fail second-line or above anti-tumor treatment
- Evaluation is stable disease with a trend of progression.
- Minimum life expectancy 16 weeks
- Histological confirmation of breast cancer on primary tumour at diagnosis/on biopsy of metastasis
- ECOG Performance Status (PS) 0-2 with no deterioration over previous 2 weeks
- Normal organ function.
- Has signed a Patient Informed Consent Form.
Exclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) score of ≥ 2
- Patients with severe liver and kidney insufficiency
- Deferoxamine Ingredients allergy
- With the exception of alopecia, any unresolved toxicities from previous therapy greater than CTCAE grade 1 before study treatment
- Inability or unwillingness to comply with study procedures, including inability to take regular oral medication
- Researchers consider it is not suitable for participation.