The Diagnostic Technology Applied Research of CDK5RAP2 in Breast Cancer

Tianjin Medical University

Status: Unknown

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01634984

CIH-ZHJ-201205001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 500 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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.