Deferoxamine Plus Chemotherapy for Metastatic Triple Negative Breast Cancer

Triple Negative Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05300958
• Other study ID #: SYSUCC-017
• Status: Recruiting
• Phase: Phase 2
• Start date: March 21, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: March 2022
• Source: Sun Yat-sen University
• Contact: Zhong-yu Yuan, M.D.
• Phone: 86208734246
• Email: yuanzhy[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 1, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Deferoxamine Plus Chemotherapy
Deferoxamine:50mg/kg+500ml normal saline (NS)

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period	6 months
Secondary	clinical benefit rate (CBR)	the proportion of patients with tumors complete response, partial response, and stable disease	6 months
Secondary	progression-free survival (PFS)	the time from the beginning of treatment for metastatic breast cancer to disease progression or death from any cause	6 months
Secondary	overal survival (OS)	the time from the beginning of treatment for metastatic breast cancer to death from any cause	12 months