The Diagnostic Technology Applied Research of CDK5RAP2 in Breast Cancer

• Conditions: Breast Cancer

• Registration Number: NCT01634984
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2012-01
• Study Start: 2012-01
• Study First Submitted: 2012-07-03
• Study First Submitted QC: 2012-07-05
• Study First Posted: 2012-07-06
• Last Update Submitted: 2015-12-21
• Last Update Posted: 2015-12-22
• Primary Completion: 2016-11
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Jin Zhang; 🇨🇳 Tianjin, China