Background: Identification of new biomarkers with potential predictive and prognostic role has contributed unequivocally to breast cancer treatment. Although traditionally endocrine therapy is based on hormonal receptors status (estrogen - ER and progesterone- PR), some patients become hormone resistant. In order to identify a possible profile associated to hormonal resistance, some biomarkers...
Date First Received: November 17, 2009
Last Updated: November 18, 2009
Verified by: Federal University of São Paulo, November 2009
Clinical Trial Phase: N/A | Start Date: April 2005
Overall Status: Completed
Estimated Enrollment: 71
Brief Summary
Official Title: “Anastrozole Reduced Proliferation and Progesterone Receptor Indexes in Short Term Hormone Therapy. A Prospective Placebo Double Blind Study”
Condition Keyword(s):
Intervention(s):
Background: Identification of new biomarkers with potential predictive and prognostic role has contributed unequivocally to breast cancer treatment.
Although traditionally endocrine therapy is based on hormonal receptors status (estrogen - ER and progesterone- PR), some patients become hormone resistant. In order to identify a possible profile associated to hormonal resistance, some biomarkers have been assessed after short period primary hormone therapy (HT).
Objectives: To compare the expression of Ki-67, Bcl2, Bax, Bak, ER and e PR in postmenopausal women with ER positive invasive ductal carcinomas (IDC), prior and after tamoxifen and anastrozole in short term hormone therapy.
Study Type: Interventional
Study Design: Basic Science, Randomized, Double-Blind, Placebo Control
Study Primary Completion Date: July 2007
Intervention(s) in this Clinical Trial
- Drug: Anastrozole
- Tamoxifen 20mg and anastrozole 1 mg
Arms, Groups and Cohorts in this Clinical Trial
- Placebo Comparator: Placebo
- Placebo
- Other: Tamoxifen
- Tamoxifen 20 mg day 26 days
- Other: Anastrozole
- Anastrozole 1mg 26 days
Outcome Measures for this Clinical Trial
Primary Measures
- Expression of progesterone
- Time Frame: end of the study (june 2008)
Safety Issue?: No
- Time Frame: end of the study (june 2008)
Secondary Measures
- Expression of Ki-67
- Time Frame: end of the study (june 2008)
Safety Issue?: No
- Time Frame: end of the study (june 2008)
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Invasive breast cancer post-menopausal women
- Estrogen and/or progesterone receptor positive
Exclusion Criteria:
- Patients with endocrine disease
- Hormone therapy users or those who had been pregnant in the last 12 months before the diagnosis
- Patients with a negative expression for estrogen and/or progesterone receptors
- Women with a history of thromboembolism
- Patients who had previously undergone any treatment for breast cancer
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 40 Years
Maximum Age for this Clinical Trial: 90 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Federal University of São Paulo
Overall Clinical Trial Officials and Contacts
Andre Mattar, MD Principal Investigator Unaffiliated.
Related Publications
References
Cuzick J, Powles T, Veronesi U, Forbes J, Edwards R, Ashley S, Boyle P. Overview of the main outcomes in breast-cancer prevention trials. Lancet. 2003 Jan 25;361(9354):296-300. Review.
Citations Reporting Results
Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 May 14-20;365(9472):1687-717.
Macaskill EJ, Renshaw L, Dixon JM. Neoadjuvant use of hormonal therapy in elderly patients with early or locally advanced hormone receptor-positive breast cancer. Oncologist. 2006 Nov-Dec;11(10):1081-8. Review.
Dowsett M. Preoperative models to evaluate endocrine strategies for breast cancer. Clin Cancer Res. 2003 Jan;9(1 Pt 2):502S-10S. Review.
Dixon JM, Renshaw L, Bellamy C, Stuart M, Hoctin-Boes G, Miller WR. The effects of neoadjuvant anastrozole (Arimidex) on tumor volume in postmenopausal women with breast cancer: a randomized, double-blind, single-center study. Clin Cancer Res. 2000 Jun;6(6):2229-35.
Harvey JM, Clark GM, Osborne CK, Allred DC. Estrogen receptor status by immunohistochemistry is superior to the ligand-binding assay for predicting response to adjuvant endocrine therapy in breast cancer. J Clin Oncol. 1999 May;17(5):1474-81.
Musgrove EA, Sutherland RL. Biological determinants of endocrine resistance in breast cancer. Nat Rev Cancer. 2009 Sep;9(9):631-43. Review.
Miller WR, Dixon JM, Cameron DA, Anderson TJ. Biological and clinical effects of aromatase inhibitors in neoadjuvant therapy. J Steroid Biochem Mol Biol. 2001 Dec;79(1-5):103-7.
Dowsett M, Smith IE, Ebbs SR, Dixon JM, Skene A, Griffith C, Boeddinghaus I, Salter J, Detre S, Hills M, Ashley S, Francis S, Walsh G, A'Hern R. Proliferation and apoptosis as markers of benefit in neoadjuvant endocrine therapy of breast cancer. Clin Cancer Res. 2006 Feb 1;12(3 Pt 2):1024s-1030s.
Konstantinidou AE, Korkolopoulou P, Patsouris E. Apoptotic markers for tumor recurrence: a minireview. Apoptosis. 2002 Oct;7(5):461-70. Review.
Ellis MJ, Tao Y, Luo J, A'Hern R, Evans DB, Bhatnagar AS, Chaudri Ross HA, von Kameke A, Miller WR, Smith I, Eiermann W, Dowsett M. Outcome prediction for estrogen receptor-positive breast cancer based on postneoadjuvant endocrine therapy tumor characteristics. J Natl Cancer Inst. 2008 Oct 1;100(19):1380-8. Epub 2008 Sep 23.
Colozza M, Azambuja E, Cardoso F, Sotiriou C, Larsimont D, Piccart MJ. Proliferative markers as prognostic and predictive tools in early breast cancer: where are we now? Ann Oncol. 2005 Nov;16(11):1723-39. Epub 2005 Jun 24. Review.
Dowsett M. Biomarker investigations from the ATAC trial: the role of TA01. Breast Cancer Res Treat. 2004;87 Suppl 1:S11-8.
Dowsett M, Ebbs SR, Dixon JM, Skene A, Griffith C, Boeddinghaus I, Salter J, Detre S, Hills M, Ashley S, Francis S, Walsh G, Smith IE. Biomarker changes during neoadjuvant anastrozole, tamoxifen, or the combination: influence of hormonal status and HER-2 in breast cancer--a study from the IMPACT trialists. J Clin Oncol. 2005 Apr 10;23(11):2477-92. Epub 2005 Mar 14.
Dowsett M, Smith IE, Ebbs SR, Dixon JM, Skene A, Griffith C, Boeddinghaus I, Salter J, Detre S, Hills M, Ashley S, Francis S, Walsh G; IMPACT Trialists. Short-term changes in Ki-67 during neoadjuvant treatment of primary breast cancer with anastrozole or tamoxifen alone or combined correlate with recurrence-free survival. Clin Cancer Res. 2005 Jan 15;11(2 Pt 2):951s-8s.
Ellis MJ, Ma C. Letrozole in the neoadjuvant setting: the P024 trial. Breast Cancer Res Treat. 2007;105 Suppl 1:33-43. Epub 2007 Oct 3. Erratum in: Breast Cancer Res Treat. 2008 Nov;112(2):371.
Additional Information
Information obtained from ClinicalTrials.gov on February 08, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01016665
Study ID Number: 0904/04
ClinicalTrials.gov Identifier: NCT01016665
Health Authority: Brazil: Ethics Committee
Clinical Trials Authorship and Review
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