Neoadjuvant Chemotherapy Response in Metaplastic Carcinoma of Triple Negative Breast Cancer (NEO-SMART)
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|ClinicalTrials.gov Identifier: NCT04549584|
Recruitment Status : Terminated (due to poor enrolled patients)
First Posted : September 16, 2020
Last Update Posted : December 17, 2020
|Condition or disease||Intervention/treatment|
|Metaplastic Breast Carcinoma||Diagnostic Test: Vimentin/pan CK stain|
Vimentin/Pan CK staining will be performed on tissues of patient who visited Seoul National University Hospital and were diagnosed with triple negative breast cancer and decided to perform neoadjuvant chemotherapy under clinical judgement.
Histologically determined to be a metaplastic breast cancer or tested positive for vimentin/Pan CK patients decides as the metaplastic breast cancer. They evaluate the response rate of the neoadjuvant chemotherapy.
Patients with vimentin/Pan CK negative are diagnosed with non-metaplastic breast cancer and this group also confirms the response rate of neoadjuvant chemotherapy.
The group of metaplastic breast cancer will enroll 50 people, and the group of non-metaplastic breast cancer will enroll 100 people.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||3 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Neoadjuvant Chemotherapy Response in Metaplastic Carcinoma of Triple Negative Breast Cancer|
|Actual Study Start Date :||October 1, 2020|
|Actual Primary Completion Date :||December 16, 2020|
|Actual Study Completion Date :||December 16, 2020|
metaplastic breast cancer
Histologically determined to be a metaplastic breast cancer or tested positive for vimentin/Pan CK patients decides as the metaplastic breast cancer.
Diagnostic Test: Vimentin/pan CK stain
Vimentin/pan CK stain positive/negative
non-metaplastic breast cancer
Patients with vimentin/Pan CK negative are diagnosed with non-metaplastic breast cancer
- response rate of neoadjuvant chemotherapy [ Time Frame: After neoadjuvant chemotherapy was finished. Average 6 month later. ]response criteria for neoadjuvant chemotherapy-complete response (CR), partial response (PR), and no response (NR)
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04549584
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Jongno-gu, Korea, Republic of, 03080|
|Principal Investigator:||Hyeong Gon Moon||Seoul National University|