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

February 10, 2020 updated by: Zhejiang Cancer Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

  • Pathologically confirmed new breast cancer (invasive cancer)
  • Clinical stage II-III
  • women
  • Aged 25-80

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
Combination product: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence Score variation after neoadjuvant chemotherapy
Time Frame: 6 months
The recurrence score of each subtype
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2019

Primary Completion (Anticipated)

March 31, 2020

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

January 29, 2020

First Submitted That Met QC Criteria

February 10, 2020

First Posted (Actual)

February 11, 2020

Study Record Updates

Last Update Posted (Actual)

February 11, 2020

Last Update Submitted That Met QC Criteria

February 10, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMTNCMB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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