Trial Information
The Diagnostic Technology Applied Research of CDK5RAP2 in Breast Cancer
The investigators selected 400 cases of women with primary breast cancer who were treated
with operation randomly,then detect the expression of CDK5RAP2 of cancer tissue. At the
same time randomly selected 100 women with primary breast cancer who were under neoadjuvant
chemotherapy. Detect the expression of CDK5RAP2 before and after neoadjuvant chemotherapy.
Inclusion Criteria:
1. Provision of informed consent
2. Pathological confirmation of breast cancer
3. Tumor stage(TNM):T2-4bN0-3M0
4. ER(+) and/or PR(+).
5. Premenopausal woman.
6. Age≥40 years
7. Measurable disease as per RECIST criteria
8. Karnofsky≥70
9. Laboratory criteria:
- PLT≥100*109/L
- WBC≥4000/mm3
- HGB≥10g/dl
- ALT and AST<2*ULN
Exclusion Criteria:
1. Presence of metastatic disease.
2. Inflammatory breast cancer.
3. Bilateral breast cancer.
4. previous chemotherapy or hormonal therapy for current breast neoplasm.
5. other malignant tumor (concurrent or previous).
6. Pregnant woman.
7. Hypersensitive to any drug in CEF regimen or any ingredient of Zoladex.
8. Any severe systemic disease contraindicating chemotherapy.
Type of Study:
Observational
Study Design:
Observational Model: Case Control, Time Perspective: Retrospective
Principal Investigator
Jin Zhang, Pro.
Investigator Role:
Study Chair
Investigator Affiliation:
TIANJIN CANCER HOSPITAL
Authority:
China: Ministry of Health
Study ID:
CIH-ZHJ-201205001
NCT ID:
NCT01634984
Start Date:
January 2012
Completion Date:
December 2013
Related Keywords:
- Breast Cancer
- expression of CDK5RAP2
- Breast Neoplasms