CClinicalTrials.gg
Sign In
TerminatedNCT04549584NEO-SMARTUpdated Dec 17, 2020

Neoadjuvant Chemotherapy Response in Metaplastic Carcinoma of Triple Negative Breast Cancer

An observational study in Metaplastic Breast Carcinoma, sponsored by Seoul National University Hospital. Terminated at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2020-12-17.

Sponsored by Seoul National University Hospital · Observational

Why this study was terminated
due to poor enrolled patients
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3
Ages
20 Years and older
Sex
All
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Metaplastic Breast Carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 3 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

  • over 20 years old
  • patients with triple negative breast cancer diagnosed Seoul National University Hospital

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

Exclusion Criteria:

  • not applicable
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3 participants (actual)
Target follow-up
2 Years
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • non-metaplastic breast cancer

    Patients with vimentin/Pan CK negative are diagnosed with non-metaplastic breast cancer

Interventions

  • Diagnostic testVimentin/pan CK stain

    Vimentin/pan CK stain positive/negative

06

What researchers measure

Primary outcomes

  1. response rate of neoadjuvant chemotherapy

    response criteria for neoadjuvant chemotherapy-complete response (CR), partial response (PR), and no response (NR)

    Time frame: After neoadjuvant chemotherapy was finished. Average 6 month later.

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, Jongno-gu 03080, Korea, Republic of
08

References and documents

Publications

  • 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. PubMed 21637948 ↗
  • 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. PubMed 24499560 ↗
  • 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. PubMed 28649648 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04549584
Lead sponsor
Seoul National University Hospital
Responsible party
Hyeong-Gon Moon (Medical doctor, Clinical Professor, Seoul National University Hospital) — Principal investigator
First posted
Sep 16, 2020
Start date
Oct 1, 2020
Primary completion
Dec 16, 2020
Completion
Dec 16, 2020
Last update
Dec 17, 2020

Study contacts

Hyeong Gon Moon
principal investigator · Seoul National University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Carcinoma→

Other studies from this sponsor

Seoul National University Hospital

Start the discussion