NCT01935739

Brief Summary

The purpose of this study is to determine discordant HER2/neu status of primary breast tumor and metastatic breast cancer cells at regional lymph nodes in node positive breast cancer patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 5, 2013

Completed
Last Updated

September 17, 2013

Status Verified

September 1, 2013

Enrollment Period

1 year

First QC Date

August 20, 2013

Last Update Submit

September 14, 2013

Conditions

Malignant Neoplasm of Breast.

Outcome Measures

Primary Outcomes (1)

  • Association of HER2/neu status between primary breast tumor and axillary lymph nodes

    Association of HER2/neu status between primary breast tumor and axillary lymph nodes was analyzed by using the χ2 test

    up to 1 year

Study Arms (2)

Primary Breast Tumor

Primary breast tumor were test for HER2/neu status.

Axillary Lymph Nodes.

Axillary Lymph Nodes were tested for HER2/neu status.

Eligibility Criteria

Age25 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Breast Cancer Patients Stage I,II and III.

You may qualify if:

  • Breast cancer patients stage I,II and III with axillary lymph nodes metastasis.

You may not qualify if:

  • Breast cancer patients stage I,II and III without axillary lymph nodes metastasis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute , Thailand.

Ratchathewi, Bangkok, 10400, Thailand

Location

Related Publications (2)

  • Cristofanilli M, Budd GT, Ellis MJ, Stopeck A, Matera J, Miller MC, Reuben JM, Doyle GV, Allard WJ, Terstappen LW, Hayes DF. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med. 2004 Aug 19;351(8):781-91. doi: 10.1056/NEJMoa040766.

    PMID: 15317891BACKGROUND

  • Cristofanilli M. The biological information obtainable from circulating tumor cells. Breast. 2009 Oct;18 Suppl 3:S38-40. doi: 10.1016/S0960-9776(09)70270-X.

    PMID: 19914540BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Paraffin embedded tissue blocks of primary breast tumor and axillary lymph nodes

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • AKANIST PIYAPANT, MD.,FRCST.

    National Cancer Institute, Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgical Oncologist.

Study Record Dates

First Submitted

August 20, 2013

First Posted

September 5, 2013

Study Start

June 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

September 17, 2013

Record last verified: 2013-09

Locations

TH(1)