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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 February 2015 |
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Main ID: |
NCT00235937 |
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Date of registration:
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10/10/2005 |
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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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Study on Pre-menopausal Patients With Advanced ER and PR + BC Treated With Arimidex Plus Zoladex
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Scientific title:
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An Open, Phase II Trial Assessing the Objective Response Rate After Combination of Arimidex® 1mg Per os/Day and Zoladex® 3.6 mg Sub Cut/Monthly as 1st Treatment for Premenopausal Receptor Positive Advanced or Metastatic Breast Cancer |
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Date of first enrolment:
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December 2001 |
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Target sample size:
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45 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00235937 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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AstraZeneca France Medical 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:
- Signed informed consent, premenopausal women 18 years or older, histologically or
cytologically confirmed locally advanced or metastatic breast cancer, suitable for
endocrine treatment, no curative treatment available,, one or more measurable
lesions, life expectancy more than 6 months, normal biological parameters.
Exclusion Criteria:
- Presence of life-threatening metastases, previous endocrine therapy or chemotherapy
for advanced or metastatic disease, any previous treatment with hormone (LH-RH)
severe or uncontrolled systemic disease, pituitary adenoma, High risk of medullar
compression.
Age minimum:
18 Years
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 and goserelin
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Primary Outcome(s)
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Determine the feasibility and efficacy of the combination of these 2 drugs in these patients
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Secondary Outcome(s)
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To assess clinical benefit rate, time to progression, duartion of response and safety in patients treated with the combination of these 2 drugs
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Secondary ID(s)
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D5390L00061 Roche Study
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THR 0104233 C
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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