Deferoxamine Plus Chemotherapy for Metastatic Triple Negative Breast Cancer

NCT ID: NCT05300958

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-21
• Study Completion Date: 2025-07-21

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.

Conditions

Triple Negative Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment arm

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

Group Type: EXPERIMENTAL

Deferoxamine Plus Chemotherapy

Intervention Type: DRUG

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

Interventions

Deferoxamine Plus Chemotherapy

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

Intervention Type: DRUG

Other Intervention Names

Chemotherapy：Treatment of Physician's Choice (TPC)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhong-yu Yuan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhong-yu Yuan, M.D.

Role: STUDY_CHAIR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

SYSUCC-017

Identifier Type: -

Identifier Source: org_study_id