Discordant HER2/Neu Status of Breast Cancer.

NCT ID: NCT01935739

Last Updated: 2013-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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HER2/neu status of primary breast tumor and axillary lymph nodes were tested by IHC staining. In the cases of equivocal result of IHC, FISH test were performed.

The result of HER2/neu status between primary breast tumor and axillary lymph node were analyzed.

Conditions

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Malignant Neoplasm of Breast.

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Primary Breast Tumor

Primary breast tumor were test for HER2/neu status.

No interventions assigned to this group

Axillary Lymph Nodes.

Axillary Lymph Nodes were tested for HER2/neu status.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Breast cancer patients stage I,II and III without axillary lymph nodes metastasis.
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute, Thailand

OTHER_GOV

Sponsor Role lead

Responsible Party

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AKANIST PIYAPANT, MD.,FRCST.

Surgical Oncologist.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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AKANIST PIYAPANT, MD.,FRCST.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute, Thailand

Locations

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National Cancer Institute , Thailand.

Ratchathewi, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type BACKGROUND
PMID: 15317891 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19914540 (View on PubMed)

Other Identifiers

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30_2013RC_IN318

Identifier Type: -

Identifier Source: org_study_id