Triple Negative Breast Cancer
Conditions
Keywords
Deferoxamine plus chemotherapy, Objective Response Rate and safety
Brief summary
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.
Detailed 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.
Interventions
DRUGDeferoxamine Plus Chemotherapy
Deferoxamine：50mg/kg+500ml normal saline (NS)
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | 6 months | the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical benefit rate (CBR) | 6 months | the proportion of patients with tumors complete response, partial response, and stable disease |
| progression-free survival (PFS) | 6 months | the time from the beginning of treatment for metastatic breast cancer to disease progression or death from any cause |
| overal survival (OS) | 12 months | the time from the beginning of treatment for metastatic breast cancer to death from any cause |
Countries
China
Outcome results
None listed