Deferoxamine Plus Chemotherapy for Metastatic Triple Negative Breast Cancer

NCT05300958 | Terminated Phase 2 DMC

• 1 other identifier: SYSUCC-017
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Triple Negative Breast Cancer

Keywords

Deferoxamine plus chemotherapy; Objective Response Rate and safety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• clinical benefit rate (CBR)

  6 months

• progression-free survival (PFS)

  6 months

• overal survival (OS)

  12 months

Study Arms (1)

Treatment arm

EXPERIMENTAL

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

Drug: Deferoxamine Plus Chemotherapy

Interventions

Deferoxamine Plus Chemotherapy DRUG

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

Also known as: Chemotherapy：Treatment of Physician's Choice (TPC)

Treatment arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Deferoxamine; Drug Therapy

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Hydroxamic Acids; Hydroxylamines; Amines; Organic Chemicals; Hydroxy Acids; Carboxylic Acids; Therapeutics

Study Officials

• Zhong-yu Yuan, M.D.

  Sun Yat-sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 20, 2022
• First Posted: March 29, 2022
• Study Start: March 21, 2022
• Primary Completion: July 21, 2025
• Study Completion: July 21, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

CN (1)