HER2 Expression Detection and Radionuclide Therapy in Breast Cancer Using 99mTc/188Re Labeled Single Domain Antibody

Inclusion Criteria:

1. Adult female, age 18 years or older

2. Prior diagnosis of breast cancer

3. Willing to participate in this study and given written informed consent

4. AST, ALT, BUN, Cr not more than double the normal values

5. Subjects of childbearing potential must be willing to undergo a pregnancy test priorto enrolment

Patients will only be included in the 188Re-NM-02 study if they meet the following supplementary criterial: HER2 postive, progression or recurrence after standard treatment, including surgery, chemotherapy, radiotherapy and targeted therapy.

Exclusion Criteria:

1. Pregnancy (subjects with a positive pregnancy test at baseline screening period orwho are planning to become pregnant during the study period)

2. Breastfeeding (subjects in lactation)

3. No biopsy tissue sample can be provided for HER2 expression detection

4. Subjects with pacemakers

5. Hepatitis B virus infection (including carriers) at screening, ie hepatitis Bsurface antigen (HBsAg) positive, or hepatitis C antibody (anti-HCV) positive, oracquired immunodeficiency disease (HIV) infected, or serum syphilis positive person

6. Abnormal liver function during baseline screening period : AST or ALT> 2 times theupper limit of normal value (ULN), if the marginal increase of a single index isjudged as having no clinical significance by the investigator, it can be retestedduring the screening period. Once, if ≤ 2 times ULN after retesting, considerenrolling).

7. Impaired renal function during screening: serum creatinine or urea nitrogen > 1.5times ULN.

8. Within 4 months prior to the baseline screening period , myocardial infarction orother cardiac events requiring hospitalization (unstable angina, etc.),cerebrovascular accident, transient ischemic attack, acute congestive Heart failureor severe arrhythmia (ventricular arrhythmia, atrioventricular block above II)

9. Subjects with pulmonary embolism or deep vein thrombosis

10. Various infections that the investigators consider unsuitable for study, includingbut not limited to patients with various infections requiring further treatment,such as urinary tract infections, respiratory infections, and diabetic footinfections.

11. Patients with abnormal thyroid function during baseline screening period (includingbut not limited to active hyperthyroidism, hypothyroidism or Hashimoto'sthyroiditis)