NCT05474391

Brief Summary

Nearly 200 cases are to be enrolled. The information of patient age, histologic grade, tumor size, ER and PR status, Ki-67 index, surgery mode should be provided. The adjuvant therapy regime (chemotherapy: none, TC\*4, TC\*6 or EC-T; endocrine therapy: TAM, OFS+TAM, OFS+AI) will be compared before and after MammaPrint testing. About 20 clinical staffs are enrolled to participate in this survey for the clinical decision making. Each case could be chosen five times at random.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

July 15, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

July 22, 2022

Last Update Submit

February 23, 2024

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Treatment decision survey

    Treatment decision change after MammaPrint testing

    6 weeks

Study Arms (1)

MammaPrint group

Pre-menopausal breast cancer patients received MammaPrint test.

Eligibility Criteria

AgeUp to 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with breast cancer (according to ICD-10)

You may qualify if:

  • pre-menopausal breast cancer patients aged less than 50 years old.
  • Pathology confirmed invasive dutal carcinoma or invasive lobular carcinoma.
  • receiving breast conserving surgery or mastectomy with/without reconstruction; sentinel lymph node biopsy or axillary lymph node dissection.
  • TNM staging: T1b-T2N0-1M0.
  • molecular subtype: ER positive/HER2 negative.
  • MammaPrint testing before initiation of adjuvant therapy.

You may not qualify if:

  • Incomplete medical history.
  • Pregnancy or lactation.
  • Contradiction of chemotherapy or ovarian function suppression.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Biyun Wang

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 22, 2022

First Posted

July 26, 2022

Study Start

July 15, 2022

Primary Completion

July 15, 2024

Study Completion

July 15, 2024

Last Updated

February 26, 2024

Record last verified: 2024-02

Locations

CN(1)