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Neoadjuvant Chemotherapy Response in Metaplastic Carcinoma of Triple Negative Breast Cancer (NEO-SMART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04549584
Recruitment Status : Terminated (due to poor enrolled patients)
First Posted : September 16, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Hyeong-Gon Moon, Seoul National University Hospital

Study Description
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Brief Summary:
prospective study for response of neoadjuvant chemotherapy in metaplastic carcinoma of triple negative breast cancer

Condition or disease Intervention/treatment
Metaplastic Breast Carcinoma Diagnostic Test: Vimentin/pan CK stain

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
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Study Type : Observational [Patient Registry]
Actual Enrollment : 3 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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
tissue obtained by core needle biopsy

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
  • over 20 years old
  • patients with triple negative breast cancer diagnosed Seoul National University Hospital
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Jongno-gu, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Hyeong Gon Moon Seoul National University
More Information
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Publications:

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Responsible Party: Hyeong-Gon Moon, Medical doctor, Clinical Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT04549584    
Other Study ID Numbers: 2004-261-112
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Triple Negative Breast Neoplasms
Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases