Combining deferoxamine with chemotherapy for advanced triple negative breast cancer
Deferoxamine Plus Chemotherapy for Metastatic Triple Negative Breast Cancer: A Single-armed, Phase II Trial
This study is testing whether adding deferoxamine to chemotherapy can help people with advanced triple negative breast cancer who are not responding well to their current treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05300958 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial aims to assess the effectiveness and safety of combining deferoxamine with chemotherapy in patients with metastatic triple negative breast cancer who have stable disease but show signs of progression after second-line treatment. The study will recruit 30 participants and is designed as a single-center, prospective, single-arm trial. Previous studies have indicated that deferoxamine may enhance the anti-tumor effects of chemotherapy, making this combination a potential new treatment approach for this challenging cancer type.
Who should consider this trial
Good fit: Ideal candidates are patients with measurable metastatic triple negative breast cancer who have experienced stable disease with a trend of progression after second-line therapy.
Not a fit: Patients with severe liver or kidney insufficiency or those who are unable to comply with study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with metastatic triple negative breast cancer who have limited options.
How similar studies have performed: While the combination of deferoxamine and chemotherapy is a novel approach, previous studies have shown promise in enhancing anti-tumor effects, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Zhong-yu Yuan, M.D.
- Email: yuanzhy@sysucc.org.cn
- Phone: 86208734246
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.