Metaplastic Breast CarcinomaNEO-SMARTNCT04549584
Neoadjuvant Chemotherapy Response in Metaplastic Carcinoma of Triple Negative Breast Cancer
An observational study of Metaplastic Breast Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
prospective study for response of neoadjuvant chemotherapy in metaplastic carcinoma of triple negative breast cancer Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Metaplastic Breast Carcinoma
- What is being tested?
- Vimentin/pan CK stain
- How many people
- 3 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2020to 16 Dec 2020
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Adult, Older adult
Study population: * over 20 years old * patients with triple negative breast cancer diagnosed Seoul National University Hospital
Who may be able to join
- 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
Who cannot join
- not applicable
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Jongno-gu, 03080
About this study
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.
- Conditions
- Metaplastic Breast Carcinoma
- Being tested
- Vimentin/pan CK stain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vimentin/pan CK stainDiagnostic test
Vimentin/pan CK stain positive/negative
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Vimentin/pan CK stain | |
| non-metaplastic breast cancer | Patients with vimentin/Pan CK negative are diagnosed with non-metaplastic breast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate of neoadjuvant chemotherapy
response criteria for neoadjuvant chemotherapy-complete response (CR), partial response (PR), and no response (NR)
Measured: After neoadjuvant chemotherapy was finished. Average 6 month later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start1 Oct 2020
- Primary completion16 Dec 2020
- Study completion16 Dec 2020
Why it stopped: due to poor enrolled patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metaplastic Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyeong-Gon Moon, Seoul National University Hospital
- Investigators
- Hyeong Gon Moon, Principal investigator, Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549584
- Sponsor's protocol ID
- 2004-261-112
- Acronym
- NEO-SMART
- Status last verified
- Jul 2020
- First submitted
- 30 Jul 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 21637948Schwartz 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 24499560Adams 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy Response in Metaplastic Carcinoma of Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT04549584
- Acronym / sponsor ID
- NEO-SMART / 2004-261-112
- Conditions
- Metaplastic Breast Carcinoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: due to poor enrolled patients
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 16 Dec 2020 (actual)
- Study completion
- 16 Dec 2020 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
prospective study for response of neoadjuvant chemotherapy in metaplastic carcinoma of triple negative breast cancer
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metaplastic breast cancer | – | Diagnostic Test: Vimentin/pan CK stainHistologically 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- * over 20 years old * patients with triple negative breast cancer diagnosed Seoul National University Hospital
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vimentin/pan CK stainVimentin/pan CK stain positive/negative | Diagnostic test | metaplastic breast cancer |
Primary outcome
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)
Results and safety
The study was stopped early (reason given: due to poor enrolled patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Background: PubMed 21637948Satelli 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.
- Background: PubMed 24499560Schwartz 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.
- Background: PubMed 28649648Adams 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyeong Gon Moon principal investigator
Seoul National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metaplastic Breast Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: due to poor enrolled patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate of neoadjuvant chemotherapy (time frame: After neoadjuvant chemotherapy was finished. Average 6 month later.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04549584, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.