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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00738777 |
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Date of registration:
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19/08/2008 |
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Primary sponsor: |
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Public title:
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Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer
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Scientific title:
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A Randomized, Prospective Trial of 2-6 Weeks Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer: Anastrozole +/- Fulvestrant or Tamoxifen Exposure - Response in Molecular Profile (AFTER-study). |
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Date of first enrolment:
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July 2008 |
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Target sample size:
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250 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00738777 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Sabine C Linn, MD |
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Address:
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Telephone:
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+31-20-5129111 |
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Email:
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s.linn@nki.nl |
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Affiliation:
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Name:
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Sabine C Linn, 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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NKI-AvL |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with proven invasive adenocarcinoma of the breast
- Any tumor with a size = 1cm (NOT inflammatory breast cancer)
- WHO-performance score 0 or 1
- Written informed consent
Exclusion Criteria:
- Clues of metastatic disease by clinical examination according to most recent NABON
guidelines
- Multicentric breast cancer
- Inflammatory breast cancer
- Hormone replacement during the last 12 months
- Other systemic treatment during the waiting time till surgery
- Already planned date for surgery within the next 2 weeks
- Any psychological, familial, sociological or geographical condition potentially
hampering adequate informed consent or compliance with the study protocol
- Patient's refusal to undergo a core biopsy procedure of the primary tumor before the
start of treatment
NB: a concomitant malignancy within the last five years is not an exclusion criterium,
because survival is not the primary endpoint. Just as prior invasive breast cancer or DCIS
within the last 15 years is not an exclusion criterium.
NB: Patients of childbearing potential must implement adequate non-hormonal contraceptive
measures during the study.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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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: Anastrozole+Fulvestrant
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Drug: Tamoxifen
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Primary Outcome(s)
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Decrease in tumor cell proliferation and induced apoptosis.
[Time Frame: At baseline and after 2-6 weeks of endocrine treatment]
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Secondary Outcome(s)
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Comparison of changes in gene expression after different endocrine treatment exposures
[Time Frame: At baseline and after endocrine treatment]
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Secondary ID(s)
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EudraCT; 2008-000644-13
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N08AFT
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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