NCT02161315

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 11, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 22, 2015

Status Verified

February 1, 2012

Enrollment Period

2.6 years

First QC Date

January 6, 2014

Last Update Submit

December 21, 2015

Conditions

Carcinoma Breast Stage IV

Keywords

SAID, Progestogens, nSAID-resistanced, LSBC

Outcome Measures

Primary Outcomes (1)

  • RECIST 1.1

    -7 days

Study Arms (2)

Observation group

Steroid Aromatase Inhibitors

Control group

Non-Steroid Aromatase Inhibitor

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

80

You may qualify if:

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

You may not qualify if:

  • Not suitable for endocrine therapy
  • Have receive the standard Steroid Aromatase Inhibitors treatment
  • Severe hepatic dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsSimian Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsSlow Virus DiseasesMonkey DiseasesPrimate DiseasesAnimal Diseases

Study Officials

  • Yehui Shi, M.D.

    Tianjin Medical University Cancer Institute and Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yehui Shi, MD

CONTACT

022-23340123-1052shiyehui@tom.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2014

First Posted

June 11, 2014

Study Start

April 1, 2014

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

December 22, 2015

Record last verified: 2012-02

Locations

CN(1)