Neoadjuvant Hormonal Treatment of Postmenopausal Women Who Have Operable Breast Cancer
| Tracking Information | |||||||||||||
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| First Received Date ICMJE | February 20, 2007 | ||||||||||||
| Last Updated Date | February 20, 2007 | ||||||||||||
| Start Date ICMJE | June 2003 | ||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||
| Current Primary Outcome Measures ICMJE |
The primary endpoint was to compare overall objective response (OR) determined by clinical (palpation) and ultrasound. | ||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | No Changes Posted | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
Secondary endpoint was the number of patients who qualified for BCS plus radiotherapy. | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Neoadjuvant Hormonal Treatment of Postmenopausal Women Who Have Operable Breast Cancer | ||||||||||||
| Official Title ICMJE | Not Provided | ||||||||||||
| Brief Summary | EFFICACY OF NEOADJUVANT ENDOCRINE THERAPY WITH ANASTROZOLE IN POMENOPAUSAL WOMEN WITH ER-POSITIVE BREAST CANCER. Flavia Morales-Vásquez, Horacio Noé López Basave. Background: Neoadjuvant Hormonal Therapy (HT) is being used increasingly to downstage locally advanced and large operable breast cancer. Following this treatment, inoperable breast cancer often becomes fully respectable and tumors requiring mastectomy may be successfully removed by breast-conserving surgery (BCS). Methods: Recruit postmenopausal women with ER(+) and/or PgR (+) breast cancer (BC) T2,N1-2 to T3,N0-1 were assigned to HT with anastrozole 1 mgr daily for 4 months. The primary endpoint was to compare overall objective response (OR) determined by clinical (palpation) and ultrasound. Secondary endpoint was the number of patients who qualified for BCS plus radiotherapy. |
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| Detailed Description | Not Provided | ||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Not Provided | ||||||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Breast Cancer | ||||||||||||
| Intervention ICMJE | Drug: Anastrozole | ||||||||||||
| Study Arm (s) | Not Provided | ||||||||||||
| Publications * | Not Provided | ||||||||||||
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* 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 | Completed | ||||||||||||
| Enrollment ICMJE | 30 | ||||||||||||
| Completion Date | February 2007 | ||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Clinical stage IIB or IIIA Tumor assessable by clinical exam, mammogram or and ultrasound Adequate functional bone marrow Documented evidence adequate renal function and liver function Life expectancy for six months Written inform consent Exclusion Criteria:
Concomitant treatment with steroids Others research drug whiting the last 30 days and concomitant use of research drugs History non compliance with medications schedules and patients consider potential unreliable. |
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| Gender | Female | ||||||||||||
| Ages | 66 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | Mexico | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00437853 | ||||||||||||
| Other Study ID Numbers ICMJE | 1033MX/0001 | ||||||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||||||
| Responsible Party | Not Provided | ||||||||||||
| Study Sponsor ICMJE | Instituto Nacional de Cancerologia de Mexico | ||||||||||||
| Collaborators ICMJE | AstraZeneca | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | Instituto Nacional de Cancerologia de Mexico | ||||||||||||
| Verification Date | February 2007 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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