Breast cancer
Conditions
Interventions
Experimental group:Received Herceptin + IV 0.3 mCi/kg 99mTc-HPArk2 Injection
Sponsors
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years, can obtain pathological diagnosis by surgery or biopsy; 2. Clinically diagnosed or diagnosed breast cancer; 3. Biopsy has confirmed metastasis to distant organs and tissues, and the diagnosis or diagnosis is HER2 receptor positive by IHC analysis, and Herceptin treatment is decided; 4. An informed consent form must be signed in writing by the subject or his legal guardian or caregiver; 5. If necessary, the subject can be accompanied by a nursing staff; 6. Before any evaluation, the subject or his legal representative understands and signs a written informed consent; 7. Female subjects must have medical records to prove that they have undergone surgical sterilization (such as hysterectomy, bilateral oophorectomy or tubal ligation) or menopause for more than one year; if they still have the ability to conceive, they must take isolated contraception during this research stage measure; 8. Willing and able to cooperate with all projects of this research.
Exclusion criteria
Exclusion criteria: 1. Suffering from gastrointestinal, cardiovascular, renal, blood system, endocrine, respiratory system, immunodeficiency or other serious diseases; 2. In the past year, due to other clinical medical or scientific research needs, they have received ionizing radiation outside the scope of this experiment, so that the annual radiation exposure dose exceeds 50 mSv; 3. History of drug or alcohol abuse; 4. Pregnant or lactating women; 5. Poor venous conditions, unable to tolerate repeated venipuncture; 6. Received (unclear effect or safety) experimental drug or device treatment within 1 month; 7. May be allergic to the components of 99mTc-HPArk2 injection; 8. Have any conditions that the research director believes that any link related to this experiment may cause harm or have potential harm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Herceptin efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| HER2 expression; | — |
Countries
China
Contacts
Public ContactSong Erwei
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Outcome results
None listed