To hear about similar clinical trials, please enter your email below
Trial Title:
Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer
NCT ID:
NCT00738777
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Tamoxifen
Fulvestrant
Anastrozole
Conditions: Keywords:
pre-operative
endocrine treatment
drug resistance
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Suspended
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Anastrozole
Description:
1 mg,QD,PO
Arm group label:
1
Intervention type:
Drug
Intervention name:
Anastrozole+Fulvestrant
Description:
Anastrozole; 1 mg, QD, PO Fulvestrant; 500 mg, IM, day 1, 15, 29 and monthly thereafter
Arm group label:
2
Intervention type:
Drug
Intervention name:
Tamoxifen
Description:
loading dose of 40 mg, TID, PO, during 7 days, Thereafter 20 mg, QD, PO
Arm group label:
3
Intervention type:
Drug
Intervention name:
Tamoxifen
Description:
loading dose of 40 mg, TID, PO, during 7 days, Thereafter 20 mg, QD, PO
Arm group label:
4
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 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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Medisch Centrum Haaglanden
Address:
City:
den Haag
Country:
Netherlands
Facility:
Name:
NKI-AVL
Address:
City:
Amsterdam
Zip:
1066 CX
Country:
Netherlands
Facility:
Name:
St. Antonius ziekenhuis
Address:
City:
Nieuwegein
Country:
Netherlands
Facility:
Name:
UMC St. Radboud
Address:
City:
Nijmegen
Country:
Netherlands
Start date:
July 2008
Completion date:
June 2024
Lead sponsor:
Agency:
The Netherlands Cancer Institute
Agency class:
Other
Collaborator:
Agency:
AstraZeneca
Agency class:
Industry
Source:
The Netherlands Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00738777
