Newly Diagnosed Breast Cancer
Conditions
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 82 Years
Inclusion criteria
Inclusion criteria: 1. The patient has newly diagnosed breast cancer with lesions classified as T1 or T2 (according to AJCC [American Joint Committee on Cancer] standards). (Note: Patients do not need to have CNS imaging to rule out CNS metastases unless symptoms are present.) 2. The patient has an easily accessible, palpable, and measurable local tumor with detection confirmed by physical examination, mammogram and/or ultrasound (U/S) and CT scan wherever possible. MRI scans may be used if appropriate. 3. The patient has histologic confirmation of diagnosis of breast cancer within 7 days prior to Day 1 of study. 4. The patient must have adequate tumor tissue for pathologic review (frozen specimen from open biopsy or core needle aspirate, or paraffin block). 5. The patient is 18 years of age or older. 6. Female patients of childbearing potential must have a negative pregnancy test at study entry and must agree to use an acceptable form of birth control for the duration of the study. 7. The patient's ECOG Performance Status is 0 to 2. 8. The patient's life expectancy is greater than 6 months. 9. The patient is able to tolerate localized injections of PTS. 10. The patient has adequate bone marrow, renal, and hepatic function as evidenced by .absolute neutrophil count = 2 x 109, .platelet count = 100 x 109, .creatinine = 177 µmol/L, .total bilirubin = 34.2 µmol/L, .SGOT and SGPT = 2 x ULN, and .alkaline phosphatase= 5 x ULN. 11. The patient must test negative for human immunodeficiency virus (HIV). 12. The patient is capable of understanding and complying with the protocol and has signed the informed consent document.
Exclusion criteria
Exclusion criteria: 1. The patient has received previous therapy or surgery for her disease. 2. The patient has a distant metastasis which requires immediate treatments. 3. The patient has a serious concomitant medical condition including an active uncontrolled infection or serious functional disorders of the heart, liver, kidneys, or blood. 4. Patient is pregnant or nursing woman. 5. The patient has a known hypersensitivity to PTS or related compounds. 6. The patient has participated in clinical studies of non-approved experimental agents or procedures within 4 weeks. 7. In addition to the study disease, patient has a history of malignancy, unless the patient is radical and sustained remission for more than 2 years. 8. The patient has had prior autologous or allogeneic transplant. 9. The patient has radiation therapy at the tumor region within 8 weeks. 10. Patient suffering from other life-threatening complications 11. The patient is unwilling to comply with study procedures, as specified by this protocol, or is unwilling to cooperate fully with the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the histologic and pathologic changes of tumor tissue & connected adjacent normal tissue;Efficacy Evaluation (RECIST & WHO Standard); | — |
Countries
China
Contacts
Public ContactGuang-Wei Xu
Outcome results
None listed