Back to resultsDeferoxamine Plus Chemotherapy for Metastatic Triple Negative Breast Cancer
Primary Purpose
Triple Negative Breast Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Deferoxamine Plus Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Triple Negative Breast Cancer focused on measuring Deferoxamine plus chemotherapy, Objective Response Rate and safety
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.
Sites / Locations
- Sun Yat-sen University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment arm
Arm Description
Deferoxamine：50mg/kg+500ml normal saline (NS) plus chemotherapy
Outcomes
Primary Outcome Measures
Objective Response Rate (ORR)
the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period
Secondary Outcome Measures
clinical benefit rate (CBR)
the proportion of patients with tumors complete response, partial response, and stable disease
progression-free survival (PFS)
the time from the beginning of treatment for metastatic breast cancer to disease progression or death from any cause
overal survival (OS)
the time from the beginning of treatment for metastatic breast cancer to death from any cause
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05300958
Brief Title
Deferoxamine Plus Chemotherapy for Metastatic Triple Negative Breast Cancer
Official Title
Deferoxamine Plus Chemotherapy for Metastatic Triple Negative Breast Cancer: A Single-armed, Phase II Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Negative Breast Cancer
Keywords
Deferoxamine plus chemotherapy, Objective Response Rate and safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment arm
Arm Type
Experimental
Arm Description
Deferoxamine：50mg/kg+500ml normal saline (NS) plus chemotherapy
Intervention Type
Drug
Intervention Name(s)
Deferoxamine Plus Chemotherapy
Other Intervention Name(s)
Chemotherapy：Treatment of Physician's Choice (TPC)
Intervention Description
Deferoxamine：50mg/kg+500ml normal saline (NS)
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period
Time Frame
6 months
Secondary Outcome Measure Information:
Title
clinical benefit rate (CBR)
Description
the proportion of patients with tumors complete response, partial response, and stable disease
Time Frame
6 months
Title
progression-free survival (PFS)
Description
the time from the beginning of treatment for metastatic breast cancer to disease progression or death from any cause
Time Frame
6 months
Title
overal survival (OS)
Description
the time from the beginning of treatment for metastatic breast cancer to death from any cause
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhong-yu Yuan, M.D.
Phone
86208734246
Email
yuanzhy@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhong-yu Yuan, M.D.
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhong-yu Yuan, MD
Phone
86-20-87342496
Email
yuanzhy@sysucc.org.cn
12. IPD Sharing Statement
Learn more about this trial
Deferoxamine Plus Chemotherapy for Metastatic Triple Negative Breast Cancer
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