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

Active, not recruiting

• Conditions: Breast cancer

• Registration Number: jRCT1030230687
• Lead Sponsor: NA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-11
• Last Update Posted: 2024-03-11

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Female
• Target Recruitment: 200000

Inclusion Criteria

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

Exclusion 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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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