breast cancer
Conditions
Interventions
Experimental group:Isosulfan Blue
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.The subject must know about the purpose, nature and method of the clinical trial, be voluntary to be a subject and sign the informed consent form; 2.Aged 18 to 70 years (including 18 and 70), all genders ; 3.Patient with axillary-node-negative and early cancer breast is diagnosed invasive breast cancer or carcinoma-in-situ in a histopathologic way; 4.Through clinical evaluation, TNM of the patient with early cancer breast is cT1-2N0M0; 5.Patient never has radio therapy of chest and breast; 6.No surgical contraindication is detected in routine preoperative examination; 7.The subject should be available all the time and keep well in touch with the Investigator, and understand and abide by all requirements for the clinical trial.
Exclusion criteria
Exclusion criteria: 1.Subject allergic to the Investigational Product and its excipients, triphenylmethane or compound related thereto, or other dyes, or having had allergic reactions to two or more drugs and foods; 2.Subject with past history of bronchial asthma and allergy; 3.Patient with inflammatory breast cancer; 4.Patient diagnosed positive axillary lymph nodes through puncture examination; 5.Patient diagnosed cancer metastasis or abnormal lymph node enlargement through clinical or radiographic examination; 6.Patient with diseased site previously treated by breast surgery and neoadjuvant chemotherapy; 7.Patient with locally advanced breast cancer; 8.Patient having any form of breast augmentation surgery before; 9.Patient with serious or out-of-control disease, such as cardiovascular and cerebrovascular diseases (blood disease, chronic congestive heart failure with NYHA>=III), serious pulmonary insufficiency and metal disorder; 10.Patient with hepatic or renal insufficiency, i.e. ALT and AST > 2.5x maximum reference value (or if liver metastasis, > 5x maximum reference value), total bilirubin > 1.5x maximum reference value and/or creatinine > 1.5x maximum reference value, or whose liver and/or kidney, as Investigators discretion, is too damaged to participate in this study; 11.Patient with serious injury and operation experience within 3 months prior to screening that as the Investigator may consider would affect efficacy and safety of the Investigational Product; 12.Subject in pregnancy or lactation or intended to have baby and refusing contraception or planning to donate her eggs during screening period and 3 months after administration; 13.Subject with one of the screened items (HBsAg, HCV-Ab, Anti-TP and Anti-HIV) positive; 14.Subject having participated in any other clinical trial in last 3 months; Patient having other conditions that should exclude it from the trial, as the Investigators discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| evaluate the efficacy of isosulfan blue injection in mapping sentinel lymph node of patients with early breast cancer; | — |
Secondary
| Measure | Time frame |
|---|---|
| evaluate the safety of isosulfan blue injection in mapping sentinel lymph node of patients with early breast cancer; | — |
Countries
China
Contacts
Public ContactFan Zhimin
Jilin University
Outcome results
None listed