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

• Conditions: Evaluation of the Value of Mammaprint Test Gene Variation in the Prediction of Neoadjuvant Chemotherapy for Breast Cancer
• Interventions: Combination Product: neoadjuvant chemotherapy

• Registration Number: NCT04264468
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2019-05-14
• Study First Submitted: 2020-01-29
• Status Verified: 2020-02
• Study First Submitted QC: 2020-02-10
• Last Update Submitted: 2020-02-10
• Study First Posted: 2020-02-11
• Last Update Posted: 2020-02-11
• Primary Completion: 2020-03-31
• Study Completion: 2021-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
response group and the non-response group	neoadjuvant chemotherapy	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).

Primary Outcome Measures

Name	Time	Method
Recurrence Score variation after neoadjuvant chemotherapy	6 months	The recurrence score of each subtype

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China