Deferoxamine Plus Chemotherapy for Metastatic Triple Negative Breast Cancer

Phase 2TerminatedNCT05300958

Sun Yat-sen University25 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Triple Negative Breast Cancer

Interventions

Deferoxamine Plus ChemotherapyDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Objective Response Rate (ORR)

the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period

Time frame: 6 months

Secondary Outcomes

clinical benefit rate (CBR)

the proportion of patients with tumors complete response, partial response, and stable disease

Time frame: 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

Time frame: 6 months

overal survival (OS)

the time from the beginning of treatment for metastatic breast cancer to death from any cause

Time frame: 12 months

Data from ClinicalTrials.gov

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