MammaPrint Value for Pre-menopausal Breast Cancer Patients

NCT ID: NCT05474391

Last Updated: 2024-02-26

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

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-15

Study Completion Date

2024-07-15

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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MammaPrint group

Pre-menopausal breast cancer patients received MammaPrint test.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Incomplete medical history.
2. Pregnancy or lactation.
3. Contradiction of chemotherapy or ovarian function suppression.
Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Biyun Wang, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Biyun Wang

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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YOUNGBC-16

Identifier Type: -

Identifier Source: org_study_id

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