The Diagnostic Technology Applied Research of CDK5RAP2 in Breast Cancer

Breast Cancer Clinical Trial

Official title:

The Diagnostic Technology Applied Research of CDK5RAP2 in Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01634984
• Other study ID #: CIH-ZHJ-201205001
• Status: Recruiting
• Phase: N/A
• First received: July 3, 2012
• Last updated: December 21, 2015
• Start date: January 2012
• Est. completion date: December 2016

Study information

• Verified date: January 2012
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Jin Zhang, Pro.
• Phone: 86-022-23340123
• Email: davidz9132002[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
China	Jin Zhang	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China,