Status:
SUSPENDED
Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer
Lead Sponsor:
The Netherlands Cancer Institute
Collaborating Sponsors:
AstraZeneca
Conditions:
Breast Cancer
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
To investigate prospectively whether short term endocrine treatment can induce molecular changes, predictive for therapy response.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00738777
Start Date
July 1 2008
End Date
June 1 2024
Last Update
January 22 2021
Active Locations (4)
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1
Medisch Centrum Haaglanden
The Hague, South Holland, Netherlands
2
NKI-AVL
Amsterdam, Netherlands, 1066 CX
3
St. Antonius ziekenhuis
Nieuwegein, Netherlands
4
UMC St. Radboud
Nijmegen, Netherlands