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

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ClinicalTrials.gov Identifier: NCT02161315
Recruitment Status : Unknown
Verified February 2012 by Tianjin Medical University Cancer Institute and Hospital.
Recruitment status was:  Recruiting
First Posted : June 11, 2014
Last Update Posted : December 22, 2015
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

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.

Condition or disease
Carcinoma Breast Stage IV

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.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Randomized Study of Steroid Aromatase Inhibitors Versus Progestogens for Non-Steroid Aromatase Inhibitor-resistanced Late Stage Breast Cancer
Study Start Date : April 2014
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Observation group
Steroid Aromatase Inhibitors
Control group
Non-Steroid Aromatase Inhibitor



Primary Outcome Measures :
  1. RECIST 1.1 [ Time Frame: -7 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
80
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161315


Contacts
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Contact: Yehui Shi, MD 022-23340123-1052 shiyehui@tom.com

Locations
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China, Tianjin
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: Yehui Shi, MD    +86-022-23340123 ext 1052    shiyehui@tom.com   
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
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Principal Investigator: Yehui Shi, M.D. Tianjin Medical University Cancer Institute and Hospital
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Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT02161315    
Other Study ID Numbers: CIH-SYH-201205001
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: February 2012
Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
SAID, Progestogens, nSAID-resistanced, LSBC
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases