Deferoxamine Plus Chemotherapy for Metastatic Triple Negative Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Deferoxamine Plus Chemotherapy for Metastatic Triple Negative Breast Cancer: A Single-armed, Phase II Trial

Conditions
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Triple Negative Breast Cancer

Intervention / Treatment
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* Drug: Deferoxamine Plus Chemotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br>Deferoxamine：50mg/kg+500ml normal saline (NS) plus chemotherapy | Drug: Deferoxamine Plus Chemotherapy<br>* Deferoxamine：50mg/kg+500ml normal saline (NS)<br>* Other names: Chemotherapy：Treatment of Physician's Choice (TPC);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical benefit rate (CBR) | the proportion of patients with tumors complete response, partial response, and stable disease | 6 months | 
| progression-free survival (PFS) | the time from the beginning of treatment for metastatic breast cancer to disease progression or death from any cause | 6 months | 
| overal survival (OS) | the time from the beginning of treatment for metastatic breast cancer to death from any cause | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deferoxamine plus chemotherapy, Objective Response Rate and safety