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A clinical randomized controlled study for the applications of carbon nanoparticles-epirubicin suspension in axillary lymph nodes targeted chemotherapy of breast cancer

A clinical randomized controlled study for the applications of carbon nanoparticles-epirubicin suspension in axillary lymph nodes targeted chemotherapy of breast cancer

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003419
Enrollment
Unknown
Registered
2013-08-05
Start date
2013-08-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Breast cancer

Interventions

targeted group:3ml carbon nanoparticles-epirubici suspension was injected into 4 points around the areola before operation
tracer group:1ml carbon nanoparticles suspension was injected into 4 points around the areola before operation
Control group:Modified radical mastectomy of breast cancer

Sponsors

Southwest Hospital, Third Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Female aged 18-70 years; 2. The diagnosis of invasive breast cancer has been confirmed by preoperative core needle biopsy; 3. Has enlarged axillary lymph nodes on preoperative examination, no axillary operation history; 4. Without distant metastasis; 5. No chest wall and breast radiotherapy history; 6. Non pregnant and lactating breast cancer; 7. Heartlungliver and kidney shoud no obvious abnormalities, no coagulation dysfunction and other operation contraindication; 8. No other malignancy; 9. Be able to follow the scheme, the patients agree to participate in the trials and sign the informed consent and date.

Exclusion criteria

Exclusion criteria: 1. Tumor distant metastasis; 2. Had axillary operation history; 3. Pregnant or lactating female patients; 4. Complicated serious disease (such as: heart exclus diseaseliver diseasekidney disease,etc) for exsist less than 2 years by estimate; 5. Patients who are not convenient to go to the doctors' office for recheck for any reason; 6. Have a particular allergy to Carbon nanoparticles or epirubicin; 7. The researchers believe that the patients are not suitable for this clinical trial for other reasons.

Design outcomes

Primary

MeasureTime frame
1, 3, 5 years relapse/ metastasize Rate; survival rate; overall survival rate;Determination of drug concentration in axillary lymph nodes;

Countries

China

Contacts

Public ContactLinjun FAN
flj212@medmail.com.cn+86 0 13389668035

Outcome results

None listed

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