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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02161315
Enrollment
80
Registered
2014-06-11
Start date
2014-04-30
Completion date
2016-12-31
Last updated
2015-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma Breast Stage IV

Keywords

SAID, Progestogens, nSAID-resistanced, LSBC

Brief 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.

Detailed 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.

Interventions

None listed

Sponsors

Tianjin Medical University Cancer Institute and Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
RECIST 1.1-7 days

Countries

China

Contacts

Primary ContactYehui Shi, MD
shiyehui@tom.com022-23340123-1052

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026