Neoadjuvant Chemotherapy Response in Metaplastic Carcinoma of Triple Negative Breast Cancer

Metaplastic Breast Carcinoma Clinical Trial

— NEO-SMART  

Official title:

Neoadjuvant Chemotherapy Response in Metaplastic Carcinoma of Triple Negative Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04549584
• Other study ID #: 2004-261-112
• Status: Terminated
• Start date: October 1, 2020
• Est. completion date: December 16, 2020

Study information

• Verified date: July 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

prospective study for response of neoadjuvant chemotherapy in metaplastic carcinoma of triple negative breast cancer

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 16, 2020
• Est. primary completion date: December 16, 2020
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• over 20 years old
• patients with triple negative breast cancer diagnosed Seoul National University Hospital
• patients who decided to perform neoadjuvant chemotherapy under clinical judgement

Exclusion Criteria:

• not applicable

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma
• Metaplastic Breast Carcinoma
• Triple Negative Breast Neoplasms

Intervention

Diagnostic Test:
• Vimentin/pan CK stain
Vimentin/pan CK stain positive/negative

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Jongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Adams S. Dramatic response of metaplastic breast cancer to chemo-immunotherapy. NPJ Breast Cancer. 2017 Mar 29;3:8. doi: 10.1038/s41523-017-0011-0. eCollection 2017. — View Citation

Satelli A, Li S. Vimentin in cancer and its potential as a molecular target for cancer therapy. Cell Mol Life Sci. 2011 Sep;68(18):3033-46. doi: 10.1007/s00018-011-0735-1. Epub 2011 Jun 3. Review. — View Citation

Schwartz TL, Mogal H, Papageorgiou C, Veerapong J, Hsueh EC. Metaplastic breast cancer: histologic characteristics, prognostic factors and systemic treatment strategies. Exp Hematol Oncol. 2013 Nov 14;2(1):31. doi: 10.1186/2162-3619-2-31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate of neoadjuvant chemotherapy	response criteria for neoadjuvant chemotherapy-complete response (CR), partial response (PR), and no response (NR)	After neoadjuvant chemotherapy was finished. Average 6 month later.