Correlation Between Molecular Typing and Neoadjuvant Chemotherapy in Breast Cancer Patients Based on Mammaprint/Blueprint Test

NCT ID: NCT04264468

Last Updated: 2020-02-11

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

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-14

Study Completion Date

2021-03-01

Brief Summary

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This study prospectively included 150 breast cancer patients (30 patients in the first stage and 120 patients in the second stage) who were treated with the commonly used neoadjuvant chemotherapy recommended by NCCN, received surgical treatment after neoadjuvant chemotherapy, and evaluated the efficacy according to the surgical pathological response.Based on the technical analysis of Mammaprint in patients with pathologic complete response (pCR), partial response and no response, we analyzed the characteristic genes related to breast cancer in tumor tissues and evaluated the accuracy and sensitivity of Mammaprint test in the efficacy of neoadjuvant chemotherapy.A new model for predicting NCT effect of breast cancer with combined risk genes and clinical parameters was established based on the clinical characteristic parameters of patients to study the accuracy and sensitivity of Mammaprint monitoring for prognosis determination of breast cancer patients.

Detailed Description

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Conditions

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Evaluation of the Value of Mammaprint Test Gene Variation in the Prediction of Neoadjuvant Chemotherapy for Breast Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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response group and the non-response group

Received neoadjuvant chemotherapy according to the routine clinical diagnosis and treatment, and evaluated the clinical efficacy once every two cycles of chemotherapy. According to the clinical efficacy, the patients were divided into the neoadjuvant chemotherapy response group and the non-response group (evaluation standard RECIST1.1).

neoadjuvant chemotherapy

Intervention Type COMBINATION_PRODUCT

This study prospectively included 150 breast cancer patients (30 patients in the first stage and 120 patients in the second stage) who were treated with the commonly used neoadjuvant chemotherapy recommended by NCCN, received surgical treatment after neoadjuvant chemotherapy, and evaluated the efficacy according to the surgical pathological response.Based on the Mammaprint technology analysis of patients with pathologic complete response (pCR), partial response and no response, we analyzed the characteristic genes related to breast cancer in the tumor tissues and evaluated the accuracy and sensitivity of the Mammaprint test for the efficacy of neoadjuvant chemotherapy

Interventions

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neoadjuvant chemotherapy

This study prospectively included 150 breast cancer patients (30 patients in the first stage and 120 patients in the second stage) who were treated with the commonly used neoadjuvant chemotherapy recommended by NCCN, received surgical treatment after neoadjuvant chemotherapy, and evaluated the efficacy according to the surgical pathological response.Based on the Mammaprint technology analysis of patients with pathologic complete response (pCR), partial response and no response, we analyzed the characteristic genes related to breast cancer in the tumor tissues and evaluated the accuracy and sensitivity of the Mammaprint test for the efficacy of neoadjuvant chemotherapy

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* Pathologically confirmed new breast cancer (invasive cancer)
* Clinical stage II-III
* women
* Aged 25-80
* At least 6 months of follow-up data, clinical diagnosis and treatment information and personal information available for follow-up are complete
* Complete biological samples required for the study: fresh/frozen tissues/white tablets/wax blocks meeting the requirements of the experiment (before neoadjuvant chemotherapy)
* Tumor markers and imaging data were complete
* Neoadjuvant chemotherapy is commonly recommended by the standard NCCN guidelines

Exclusion Criteria

* Subjects refuse to participate
* First diagnosis of stage I or IV breast cancer
* Pathological diagnosis of concurrent (or previous) other malignant tumors
* Prehistory breast cancer
* Younger than 25 or older than 80
* Clinical diagnosis and treatment information or biological samples required by the research institute do not meet the needs of the experiment
Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xing fei Yu, doctoral degree

Role: CONTACT

+86-13588164600

Facility Contacts

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Jingjie Li, master

Role: primary

+86-17310738793

Other Identifiers

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CMTNCMB

Identifier Type: -

Identifier Source: org_study_id

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