Deferoxamine Plus Chemotherapy for Metastatic Triple Negative Breast Cancer

July 20, 2025 updated by: Zhong-yu Yuan, Sun Yat-sen University

Deferoxamine Plus Chemotherapy for Metastatic Triple Negative Breast Cancer: A Single-armed, Phase II Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment arm
Deferoxamine：50mg/kg+500ml normal saline (NS) plus chemotherapy
Drug: Deferoxamine Plus Chemotherapy
Deferoxamine：50mg/kg+500ml normal saline (NS)
Other Names:
  • Chemotherapy：Treatment of Physician's Choice (TPC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: 6 months
the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical benefit rate (CBR)
Time Frame: 6 months
the proportion of patients with tumors complete response, partial response, and stable disease
6 months
progression-free survival (PFS)
Time Frame: 6 months
the time from the beginning of treatment for metastatic breast cancer to disease progression or death from any cause
6 months
overal survival (OS)
Time Frame: 12 months
the time from the beginning of treatment for metastatic breast cancer to death from any cause
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Study Chair: Zhong-yu Yuan, M.D., Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2022

Primary Completion (Actual)

July 21, 2025

Study Completion (Actual)

July 21, 2025

Study Registration Dates

First Submitted

March 20, 2022

First Submitted That Met QC Criteria

March 28, 2022

First Posted (Actual)

March 29, 2022

Study Record Updates

Last Update Posted (Actual)

July 22, 2025

Last Update Submitted That Met QC Criteria

July 20, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSUCC-017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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