Study on clinicopathological characteristics and prognosis of ER-low positive breast cancer using National Clinical Database-Breast Cancer Registry

JRCT ID: jRCT1030230687

Registered date:11/03/2024

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Breast cancer
• Date of first enrollment: 11/03/2024
• Target sample size: 200000
• Study type: Observational

Outcome(s)

Primary Outcome

Disease-free survival, Breast Cancer Specific Survival, and Overall Survival in tumors with ER<1%, 1%<=ER<10%, and ER>=10%, respectively

Disease-free survival, Breast Cancer Specific Survival, and Overall Survival with and without perioperative endocrine therapy and chemotherapy in tumors with 1%<=ER<10

Secondary Outcome

Disease-free survival, Breast Cancer Specific Survival, and Overall Survival with perioperative chemotherapy regimens (anthracycline alone, taxane alone, anthracycline + taxane) in tumors with 1%<= ER<10 Survival, Breast Cancer Specific Survival, Overall Survival

Clinico-pathological background (age, premenopausal/postmenopausal, histology, stage, lymph node metastasis, PgR, surgery type, perioperative treatment, pathological complete response (pCR) rate in preoperative chemotherapy cases) for ER<1%, 1%<=ER<10% and ER>=10%, respectively

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Female

Include criteria

1. Patients with primary breast cancer registered in the NCD
2. Patients with Stage I-III breast cancer who have undergone surgery

Exclude criteria

1. non-invasive carcinoma (Tis)
2. Stage IV at diagnosis
3. Metastatic or recurrent breast cancer
4. Occult breast cancer (T0, TX)
5. HER2-positive breast cancer (immunostaining or FISH)
6. Male breast cancer
7. Synchronous or non-synchronous bilateral breast cancer
8. Preoperative radiotherapy cases

Related Information

• Primary Sponsor: Hayashida Tetsu