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

Carcinoma Breast Stage IV Clinical Trial

Official title:

A Randomized Study of Steroid Aromatase Inhibitors Versus Progestogens for Non-Steroid Aromatase Inhibitor-resistanced Late Stage Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02161315
• Other study ID #: CIH-SYH-201205001
• Status: Recruiting
• Phase: N/A
• First received: January 6, 2014
• Last updated: December 21, 2015
• Start date: April 2014
• Est. completion date: December 2016

Study information

• Verified date: February 2012
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Yehui Shi, MD
• Phone: 022-23340123-1052
• Email: shiyehui[@]tom.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma Breast Stage IV

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RECIST 1.1		-7 days	Yes