MammaPrint Value for Pre-menopausal Breast Cancer Patients

Fudan University

Status: Active, not recruiting

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05474391

YOUNGBC-16

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: Under 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

MammaPrint group

Description:

Pre-menopausal breast cancer patients received MammaPrint test.