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Deferoxamine Plus Chemotherapy for Metastatic Triple Negative Breast Cancer

Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05300958
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
30.4
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Deferoxamine Plus Chemotherapy
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Deferoxamine Plus Chemotherapy for Metastatic Triple Negative Breast Cancer: A Single-armed, Phase II Trial
Actual Study Start Date :
Mar 21, 2022
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. clinical benefit rate (CBR) [6 months]

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

    2. 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

    3. overal survival (OS) [12 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sun Yat-sen University Cancer Center Guangzhou Guangdong China 510060

    Sponsors and Collaborators

    • Sun Yat-sen University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhong-yu Yuan, Professor, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT05300958
    Other Study ID Numbers:
    • SYSUCC-017
    First Posted:
    Mar 29, 2022
    Last Update Posted:
    Mar 29, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zhong-yu Yuan, Professor, Sun Yat-sen University
    Deferoxamine plus chemotherapy
    Objective Response Rate and safety
    Additional relevant MeSH terms:
    Breast Neoplasms
    Triple Negative Breast Neoplasms
    Deferoxamine

    Study Results

    No Results Posted as of Mar 29, 2022