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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00357110 |
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Date of registration:
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20/07/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Anastrozole and Fulvestrant Compared to Anastrozole as Adjuvant Treatment of Postmenopausal Patients With Breast Cancer
@FAME |
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Scientific title:
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A Randomised Phase II Study Comparing Anastrozole and Fulvestrant to Anastrozole for Adjuvant Treatment of Postmenopausal Patients With Early Breast Cancer and Disseminated Tumour Cells in Bone Marrow |
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Date of first enrolment:
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April 2006 |
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Target sample size:
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13 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00357110 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Austria
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Germany
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Norway
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Contacts
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Name:
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Breast Cancer Established Brands Team Medical Science Director, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Postmenopausal women with hormone receptor-positive early breast cancer and a positive
Disseminated Tumour Cell immunocytochemical result from bone marrow aspiration prior
to randomisation
Exclusion Criteria:
- Inflammatory and/or metastatic breast cancer.
- Current or previous malignancy within previous 5 years (other than Breast cancer or
adequately treated non-melanoma skin cancer or in-situ cervical cancer).
- History of bleeding diathesis.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Drug: Anastrozole
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Drug: Fulvestrant
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Primary Outcome(s)
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Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence)
[Time Frame: 12 month period following randomisation]
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Secondary ID(s)
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D6990C00001
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Eudract No 2005-005715-22
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ABCSG21
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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