Study Stopped
due to poor enrolled patients
Neoadjuvant Chemotherapy Response in Metaplastic Carcinoma of Triple Negative Breast Cancer
NEO-SMART
1 other identifier
observational
3
1 country
1
Brief Summary
prospective study for response of neoadjuvant chemotherapy in metaplastic carcinoma of triple negative breast cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2020
Shorter than P25 for all trials
1 active site
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
First Submitted
Initial submission to the registry
July 30, 2020
CompletedFirst Posted
Study publicly available on registry
September 16, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 16, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 16, 2020
CompletedDecember 17, 2020
July 1, 2020
3 months
July 30, 2020
December 15, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (2)
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.
non-metaplastic breast cancer
Patients with vimentin/Pan CK negative are diagnosed with non-metaplastic breast cancer
Interventions
Vimentin/pan CK stain positive/negative
Eligibility Criteria
* over 20 years old * patients with triple negative breast cancer diagnosed Seoul National University Hospital
You may qualify if:
- 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
You may not qualify if:
- not applicable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, Jongno-gu, 03080, South Korea
Related Publications (3)
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.
PMID: 21637948BACKGROUNDSchwartz 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.
PMID: 24499560BACKGROUNDAdams 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.
PMID: 28649648BACKGROUND
Biospecimen
tissue obtained by core needle biopsy
Study Officials
- PRINCIPAL INVESTIGATOR
Hyeong Gon Moon
Seoul National University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical doctor, Clinical Professor
Study Record Dates
First Submitted
July 30, 2020
First Posted
September 16, 2020
Study Start
October 1, 2020
Primary Completion
December 16, 2020
Study Completion
December 16, 2020
Last Updated
December 17, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share