Deferoxamine Plus Chemotherapy for Metastatic Triple Negative Breast Cancer

Sun Yat-sen University

Status and phase: Terminated; Phase 2

Conditions: Triple Negative Breast Cancer

Treatments: Drug: Deferoxamine Plus Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05300958

SYSUCC-017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Treatment arm

Experimental group

Description:

Deferoxamine：50mg/kg+500ml normal saline (NS) plus chemotherapy

Treatment:

Drug: Deferoxamine Plus Chemotherapy