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).
N/A
N/A
Both
Breast Cancer
Trial Information
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).
We will perform a randomized, open-label, single-institution study. It will compare the
efficacy of three different endocrine treatment regimens (Anastrozole +/- Fulvestrant or
Tamoxifen) in changing proliferation-index and inducing apoptosis during a 2-6 week
pre-operative treatment period in breast cancer patients. These results will be correlated
to gene expression profiles, phosphorylation status of the ER, SNPs in CYP450 sequences,
tamoxifen metabolite concentrations, changes in estrogen serum levels and protein expression
patterns.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Outcome Measure:
Decrease in tumor cell proliferation and induced apoptosis.
Outcome Time Frame:
At baseline and after 2-6 weeks of endocrine treatment
Safety Issue:
No
Principal Investigator
Sabine C Linn, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
NKI-AvL
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
N08AFT
NCT ID:
NCT00738777
Start Date:
July 2008
Completion Date:
June 2014
Related Keywords:
- Breast Cancer
- pre-operative
- endocrine treatment
- drug resistance
- Breast Neoplasms
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