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Phase I clinical trial of interstitial implant brachytherapy in local treatment of early breast cancer

Phase I clinical trial of interstitial implant brachytherapy in local treatment of early breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021366
Enrollment
Unknown
Registered
2019-02-17
Start date
2019-03-01
Completion date
Unknown
Last updated
2019-02-18

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

Conditions

Breast cancer

Interventions

Case series:implantation radiotherapy

Sponsors

the Affiliated Hospital of Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Pathologically confirmed early breast cancer patients (T1-2N0M0): (1) patients with absolute surgical contraindications; (2) patients who refuse surgical treatment; 2. Aged 18 years or above; 3. No contraindication of radiotherapy. The survival time is expected to be greater than 6 months; 4. ZPS score 0-2 points; 5. HCG of urine and serum was negative in 72 hours before treatment; 6. Bone marrow function is normal, as follows: white blood cell count > 3.5 *109/L, hemoglobin > 90 g/L (without blood transfusion), neutrophil count (> 2.0 *109/L), platelet count (> 100 *109/L), serum creatinine clearance rate (> 60 ml/min), ALT, AST < 2.5 times normal reference value. Bilirubin is within normal limits; 7. Coagulation function was normal: PT 12-16s, INR 0.8-1.5, APTT 24-36s, FIB2-4g/L. Pre-transfusion tests: HIV and TP were negative (-); 8. No allergic history of narcotics, such as lidocaine; 9. informed consent and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. There is a history of serious cardiovascular diseases, such as uncontrolled hypertension, unstable angina, congestive heart failure, acute myocardial infarction, and transmural myocardial infarction within 6 months; 2. Combined with uncontrolled neuropathy (grade 2 or above) or psychotic patients; 3. Systemic distant metastasis was not effectively controlled; 4. Patients with acute bacterial or fungal infections need intravenous anti infective treatment; 5. Liver dysfunction causes jaundice or coagulopathy; 6. Pregnant or child-bearing age women refuse to adopt appropriate contraceptive measures.

Design outcomes

Primary

MeasureTime frame
Breast mass;Breast mass;

Countries

China

Contacts

Public ContactYang HongRu

Oncology Department, the Affiliated Hospital of Southwest Medical University

343922738@qq.com+86 18583068203

Outcome results

None listed

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