MammaPrint Value for Pre-menopausal Breast Cancer Patients
Active, not recruiting
- Conditions
- Breast Cancer
- Registration Number
- NCT05474391
- Lead Sponsor
- Fudan University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 200
Inclusion Criteria
- 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.
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Exclusion Criteria
- Incomplete medical history.
- Pregnancy or lactation.
- Contradiction of chemotherapy or ovarian function suppression.
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment decision survey 6 weeks Treatment decision change after MammaPrint testing
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China