Anastrozole in Treating Postmenopausal Women With DCIS or Stage I-III Breast Cancer
Tracking Information | |||||
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First Received Date ICMJE | October 25, 2005 | ||||
Last Updated Date | June 11, 2012 | ||||
Start Date ICMJE | January 2004 | ||||
Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change in breast density after 12 months of treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
Change in breast density after 12 months of treatment | ||||
Change History | Complete list of historical versions of study NCT00244959 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Anastrozole in Treating Postmenopausal Women With DCIS or Stage I-III Breast Cancer | ||||
Official Title ICMJE | Surrogate Markers of Response: A Phase II Study of Changes in Breast Density Among Postmenopausal Women Receiving Adjuvant Anastrozole Therapy | ||||
Brief Summary | RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by lowering the amount of estrogen the body makes. PURPOSE: This phase II trial is studying how anastrozole effects postmenopausal women who have undergone surgery for ductal carcinoma in situ or stage I, stage II, or stage III breast cancer. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a pilot study. Patients are stratified according to concurrent bisphosphonate use (yes vs no). Patients receive oral anastrozole once daily for up to 12 months in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Breast Cancer | ||||
Intervention ICMJE |
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Study Arm (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Enrollment ICMJE | 54 | ||||
Estimated Completion Date | December 2012 | ||||
Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY: Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Female | ||||
Ages | |||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00244959 | ||||
Other Study ID Numbers ICMJE | J0365 CDR0000446285, P30CA006973, JHOC-J0365, JHOC-SKCCC-J0365, JHOC-IRB-03100706 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Sidney Kimmel Comprehensive Cancer Center | ||||
Study Sponsor ICMJE | Sidney Kimmel Comprehensive Cancer Center | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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Information Provided By | Sidney Kimmel Comprehensive Cancer Center | ||||
Verification Date | June 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |