Discordant HER2/Neu Status of Breast Cancer.

Malignant Neoplasm of Breast. Clinical Trial

Official title:

Discordant HER2/Neu Status Between Primary Tumor and Axillary Lymph Node in Breast Cancer Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01935739
• Other study ID #: 30_2013RC_IN318
• Status: Completed
• Phase: N/A
• First received: August 20, 2013
• Last updated: September 14, 2013
• Start date: June 2010
• Est. completion date: June 2011

Study information

• Verified date: September 2013
• Source: National Cancer Institute, Thailand
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 70 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms
• Malignant Neoplasm of Breast.
• Neoplasms

Locations

Country	Name	City	State
Thailand	National Cancer Institute , Thailand.	Ratchathewi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Thailand

Country where clinical trial is conducted

Thailand, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ?2 test	up to 1 year	No