Steroid Aromatase Inhibitors Versus Progestogens for nSAID-resistanced Late Stage Breast Cancer

Tianjin Medical University

Status: Unknown

Conditions: Carcinoma Breast Stage IV

Study type: Observational

Funder types: Other

Identifiers

NCT02161315

CIH-SYH-201205001

Details and patient eligibility

About

Steroid Aromatase Inhibitors and Non-Steroid Aromatase Inhibitors in Late Stage Breast Cancer is the recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. In the past controlled clinical trials with small sample.

Full description

A Randomized Study of Steroid Aromatase Inhibitors Versus Progestogens for Non-Steroid Aromatase Inhibitor-resistanced Late Stage Breast Cancer.The primary endpoints of the study is progression free survival (PFS). The secondary endpoints are overall response rate (ORR), overall survival (OS) and safety.

Enrollment: 80 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients must be the postmenopausal women
2. Patients must be diagnosed with advanced breast cancer by imageology，cytology or histopathology
3. Immunohistochemistry shows ER and/or PR positive
4. Patients ECOG score must be 0-2
5. Drug resistant about Non-Steroid Aromatase Inhibitors

Exclusion criteria

1. Not suitable for endocrine therapy
2. Have receive the standard Steroid Aromatase Inhibitors treatment
3. Severe hepatic dysfunction

Trial design

80 participants in 2 patient groups

Observation group

Description:

Steroid Aromatase Inhibitors

Control group

Description:

Non-Steroid Aromatase Inhibitor