NCT01634984

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 6, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 22, 2015

Status Verified

January 1, 2012

Enrollment Period

4.8 years

First QC Date

July 3, 2012

Last Update Submit

December 21, 2015

Conditions

Breast Cancer

Keywords

expression of CDK5RAP2

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

500 patients with breast cancer

You may qualify if:

  • Provision of informed consent
  • Pathological confirmation of breast cancer
  • Tumor stage(TNM):T2-4bN0-3M0
  • ER(+) and/or PR(+).
  • Premenopausal woman.
  • Age≥40 years
  • Measurable disease as per RECIST criteria
  • Karnofsky≥70
  • Laboratory criteria:
  • PLT≥100\*109/L
  • WBC≥4000/mm3
  • HGB≥10g/dl
  • ALT and AST\<2\*ULN

You may not qualify if:

  • Presence of metastatic disease.
  • Inflammatory breast cancer.
  • Bilateral breast cancer.
  • previous chemotherapy or hormonal therapy for current breast neoplasm.
  • other malignant tumor (concurrent or previous).
  • Pregnant woman.
  • Hypersensitive to any drug in CEF regimen or any ingredient of Zoladex.
  • Any severe systemic disease contraindicating chemotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jin Zhang

Tianjin, 300000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jin Zhang, Pro.

    Tianjin Cancer Hospital

    STUDY CHAIR

Central Study Contacts

Jin Zhang, Pro.

CONTACT

86-022-23340123davidz9132002@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2012

First Posted

July 6, 2012

Study Start

January 1, 2012

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

December 22, 2015

Record last verified: 2012-01

Locations

CN(1)