Triple Negative Breast CancerPhase 2NCT05300958
Deferoxamine Plus Chemotherapy for Metastatic Triple Negative Breast Cancer
A Phase 2 study testing Deferoxamine Plus Chemotherapy in people with Triple Negative Breast Cancer, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- Deferoxamine Plus Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2022to 21 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Deferoxamine Plus Chemotherapy
- Keywords
- Deferoxamine plus chemotherapy, Objective Response Rate and safety
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deferoxamine Plus ChemotherapyDrug
Also called Chemotherapy：Treatment of Physician's Choice (TPC)
Deferoxamine：50mg/kg+500ml normal saline (NS)
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Deferoxamine：50mg/kg+500ml normal saline (NS) plus chemotherapy Receives: Drug: Deferoxamine Plus Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period
Measured: 6 months
Secondary outcomes (3)
clinical benefit rate (CBR)
the proportion of patients with tumors complete response, partial response, and stable disease
Measured: 6 months
progression-free survival (PFS)
the time from the beginning of treatment for metastatic breast cancer to disease progression or death from any cause
Measured: 6 months
overal survival (OS)
the time from the beginning of treatment for metastatic breast cancer to death from any cause
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start21 Mar 2022
- Primary completion21 Jul 2025
- Study completion21 Jul 2025
Why it stopped: Difficulty accruing subjects the study accrual was closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhong-yu Yuan, Sun Yat-sen University
- Investigators
- Zhong-yu Yuan, M.D., Study chair, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300958
- Sponsor's protocol ID
- SYSUCC-017
- Status last verified
- Jul 2025
- First submitted
- 20 Mar 2022
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deferoxamine Plus Chemotherapy for Metastatic Triple Negative Breast Cancer: A Single-armed, Phase II Trial
- ClinicalTrials.gov ID
- NCT05300958
- Acronym / sponsor ID
- SYSUCC-017
- Conditions
- Triple Negative Breast Cancer
- Keywords
- Deferoxamine plus chemotherapy, Objective Response Rate and safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty accruing subjects the study accrual was closed.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 21 Jul 2025 (actual)
- Study completion
- 21 Jul 2025 (actual)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Deferoxamine Plus ChemotherapyDeferoxamine：50mg/kg+500ml normal saline (NS) plus chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deferoxamine Plus ChemotherapyAlso: Chemotherapy：Treatment of Physician's Choice (TPC)Deferoxamine：50mg/kg+500ml normal saline (NS) | Drug | Treatment arm |
Primary outcome
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
3 secondary outcomes
clinical benefit rate (CBR)
Time frame: 6 months
progression-free survival (PFS)
Time frame: 6 months
overal survival (OS)
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Difficulty accruing subjects the study accrual was closed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhong-yu Yuan, M.D. study chair
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Deferoxamine Plus Chemotherapy in people with Triple Negative Breast Cancer, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty accruing subjects the study accrual was closed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.