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A prospective phase II clinical study of radiotherapy combined with dihydroartemisinin (DHA) in the treatment of brain metastases from breast cancer

A prospective phase II clinical study of radiotherapy combined with dihydroartemisinin (DHA) in the treatment of brain metastases from breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103939
Enrollment
Unknown
Registered
2025-06-09
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

Single arm:dihydroartemisinin was administered during radiotherapy

Sponsors

Yunnan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. voluntarily participate and sign the informed consent form in person; 2. Chinese women aged > 18 to =70, predicted survival longer than 3 months; 7. to obtain the results of ER, PR, HER2 and Ki-67 of primary breast lesions; 8. Women of child-bearing age, should use contraception for at least one month before screening and commit to use contraception for the entire duration of the study and for a specified period after the study.

Exclusion criteria

Exclusion criteria: 1. patients with leptomeningeal metastasis considered by imaging; 2. the number of intracranial metastases > 10; 3. pregnant or lactating women; 4. Patients with serious non-neoplastic medical complications, which may affect the implementation of radiotherapy; 5. liver and kidney dysfunction > 1.5 times normal value, as assessed by the investigator, affecting drug users; 6. allergic or intolerant to DHA. 7. history of malignant tumors within the past 5 years (excluding previous lobular carcinoma in situ, skin basal cell carcinoma, skin carcinoma in situ, and cervical carcinoma in situ); 8. patients unable or unwilling to receive radiotherapy.

Design outcomes

Primary

MeasureTime frame
Intracranial control rates at 6 months, 1 year, and 2 years;

Secondary

MeasureTime frame
There was no extracranial distant metastasis rate at 6 months, 1 year, and 2 years;Intracranial recurrence-free survival at 6 months, 1 year, and 2 years;6 months, 1 year, and 2 years overall survival;Acute and chronic radiation-related adverse reactions;Drug-related adverse reactions;Quality of Life Evaluation;

Countries

China

Contacts

Public ContactLi Wenhui

Yunnan Cancer Hospital

wangli20060521@126.com+86 153 9849 5669

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026