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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04549584
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Actual Duration (Months): 2.5
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 3 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Neoadjuvant Chemotherapy Response in Metaplastic Carcinoma of Triple Negative Breast Cancer
• Actual Study Start Date: Oct 1, 2020
• Actual Primary Completion Date: Dec 16, 2020
• Actual Study Completion Date: Dec 16, 2020

Arms and Interventions

Arm	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

Primary Outcome Measures

1. response rate of neoadjuvant chemotherapy [After neoadjuvant chemotherapy was finished. Average 6 month later.]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All

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

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul	Jongno-gu	Korea, Republic of	03080

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Principal Investigator: Hyeong Gon Moon, Seoul National University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• 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: Sep 16, 2020
• Last Update Posted: Dec 17, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Triple Negative Breast Neoplasms; Breast Neoplasms

Study Results

No Results Posted as of Dec 17, 2020