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

NCT ID: NCT02161315

Last Updated: 2015-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Carcinoma Breast Stage IV

Keywords

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SAID, Progestogens, nSAID-resistanced, LSBC

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Observation group

Steroid Aromatase Inhibitors

No interventions assigned to this group

Control group

Non-Steroid Aromatase Inhibitor

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yehui Shi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Cancer Institute and Hospital

Locations

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Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yehui Shi, MD

Role: CONTACT

Phone: 022-23340123-1052

Email: [email protected]

Facility Contacts

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Yehui Shi, MD

Role: primary

Other Identifiers

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CIH-SYH-201205001

Identifier Type: -

Identifier Source: org_study_id