Deferoxamine Plus Chemotherapy for Metastatic Triple Negative Breast Cancer

Phase 2

Recruiting

• Conditions: Triple Negative Breast Cancer
• Interventions: Drug: Deferoxamine Plus Chemotherapy

• Registration Number: NCT05300958
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study First Submitted: 2022-03-20
• Study Start: 2022-03-21
• Study First Submitted QC: 2022-03-28
• Study First Posted: 2022-03-29
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-08-01
• Primary Completion: 2025-07-30
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment arm	Deferoxamine Plus Chemotherapy	Deferoxamine：50mg/kg+500ml normal saline (NS) plus chemotherapy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
clinical benefit rate (CBR)	6 months	the proportion of patients with tumors complete response, partial response, and stable disease

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China