CT-based Radiomics of ALN pCR (ypN0) in Breast Cancer Undergoing NAC

NCT ID: NCT04457700

Last Updated: 2022-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

218 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-12-30

Brief Summary

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This is a prospective, single-center, non-randomized, non-controlled observational study.

Detailed Description

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Almost 55-62% of patients with triple-negative or human epidermal growth factor receptor 2 (HER2) positive, node-positive breast cancer achieve an axillary pathologic complete remission (pCR) after neoadjuvant chemotherapy (NAC). To avoid surgery post-NAC, it is paramount to accurately identify patients who achieve pCR in axillary lymph node (ALN). We found that patients with normal-appearing lymph nodes on computed tomography (CT) based radiomics of the axilla after chemotherapy had a lower risk of developing residual nodal disease. However, the features of CT-based radiomics for pCR ALN following NAC has not been established yet. This study aimed to assess the performance of CT-based radiomics in evaluating the response and predicting pCR of metastatic lymph nodes after NAC in breast cancer patients.

Conditions

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Triple-negative Breast Cancer HER2-positive Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Triple-negative and HER2 Positive breast cancer

Patients with triple-negative or HER2 Positive breast cancer, axillary lymph node metastasis who underwent NAC are eligible for this study. Axillary lymph node metastasis is confirmed by fine needle aspiration (FNA) or core needle biopsy (CNB) at initial diagnosis. CT-based radiomics will be uesd in evaluating the response and predicting pCR of metastatic lymph nodes after NAC in breast cancer patients.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Triple-negative or HER2-positve invasive breast cancer with axillary lymph node metastasis by confirmed by fine needle aspiration or core needle biopsy.
* Underwent computed tomography for assessment of axillary lymph node status before and after neoadjuvant chemotherapy.
* Attend the study voluntarily, sign the informed consent.

Exclusion Criteria

* Contradiction for adjuvant chemotherapy.
* Contradiction for proceeding surgery.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking University

OTHER

Sponsor Role lead

Responsible Party

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Tao OUYANG

Director of Breast Center of Peking University Cancer Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lize Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Breast center at Peking University Cancer Hospital

Locations

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Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lize Wang, MD

Role: CONTACT

+86-10-88271119 ext. 5001

Yingjian He, MD

Role: CONTACT

+86-10-88271119 ext. 8018

Facility Contacts

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Lize Wang, MD

Role: primary

+86-10-88271119 ext. 8018

Other Identifiers

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BCP28

Identifier Type: -

Identifier Source: org_study_id

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