NCT04264468

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

11 months

First QC Date

January 29, 2020

Last Update Submit

February 10, 2020

Conditions

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

Keywords

neoadjuvant chemotherapyMammaprintblueprintprognosis

Outcome Measures

Primary Outcomes (1)

  • Recurrence Score variation after neoadjuvant chemotherapy

    The recurrence score of each subtype

    6 months

Study Arms (1)

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

Interventions

neoadjuvant chemotherapyCOMBINATION_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

response group and the non-response group

Eligibility Criteria

Age25 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Interventions

Neoadjuvant Therapy

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Central Study Contacts

Xing fei Yu, doctoral degree

CONTACT

+86-13588164600yuxf1177@zjcc.org.cn

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2020

First Posted

February 11, 2020

Study Start

May 14, 2019

Primary Completion

March 31, 2020

Study Completion

March 1, 2021

Last Updated

February 11, 2020

Record last verified: 2020-02

Locations

CN(1)