Post Operative Adjuvant Chemotherapy Followed by Adjuvant Tamoxifen vs Nil for Patients With Operable Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tamoxifen
Sponsored by
About this trial
This is an interventional health services research trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients with operable breast cancer
Sites / Locations
Outcomes
Primary Outcome Measures
safety
Secondary Outcome Measures
Full Information
NCT ID
NCT00538330
First Posted
October 1, 2007
Last Updated
December 11, 2011
Sponsor
King Faisal Specialist Hospital & Research Center
1. Study Identification
Unique Protocol Identification Number
NCT00538330
Brief Title
Post Operative Adjuvant Chemotherapy Followed by Adjuvant Tamoxifen vs Nil for Patients With Operable Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Faisal Specialist Hospital & Research Center
4. Oversight
5. Study Description
Brief Summary
Post operative adjuvant chemotherapy followed by adjuvant Tamoxifen vs nil for patients with operable breast cancer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tamoxifen
Intervention Description
Tamoxifen
Primary Outcome Measure Information:
Title
safety
Time Frame
10 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with operable breast cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adnan Ezzat, MD
Organizational Affiliation
KFSH&RC, Riyadh
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Post Operative Adjuvant Chemotherapy Followed by Adjuvant Tamoxifen vs Nil for Patients With Operable Breast Cancer
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