Anastrozole Reduced Proliferation and Progesterone Receptor Indexes in Short Term Hormone Therapy

NCT01016665 | Completed

• 1 other identifier: 0904/04
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast cancer; Short Term; Homontherapy; aromatase inhibitor; Short term hormonetherapy in breast cancer

Outcome Measures

Primary Outcomes (1)

• Expression of progesterone

  end of the study (june 2008)

Secondary Outcomes (1)

• Expression of Ki-67

  end of the study (june 2008)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Anastrozole

Tamoxifen

OTHER

Tamoxifen 20 mg day 26 days

Drug: Anastrozole

Anastrozole

OTHER

Anastrozole 1mg 26 days

Drug: Anastrozole

Interventions

Anastrozole DRUG

Tamoxifen 20mg and anastrozole 1 mg

Anastrozole; Placebo; Tamoxifen

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Invasive breast cancer post-menopausal women
• Estrogen and/or progesterone receptor positive

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Sao Paulo Federal University

São Paulo, São Paulo, 01530020, Brazil

Location

Related Publications (16)

• 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. doi: 10.1016/S0140-6736(03)12342-2.

  PMID: 12559863 BACKGROUND

• 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. doi: 10.1016/S0140-6736(05)66544-0.

  PMID: 15894097 RESULT

• 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. doi: 10.1634/theoncologist.11-10-1081.

  PMID: 17110627 RESULT

• Dowsett M. Preoperative models to evaluate endocrine strategies for breast cancer. Clin Cancer Res. 2003 Jan;9(1 Pt 2):502S-10S.

  PMID: 12538507 RESULT

• 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.

  PMID: 10873072 RESULT

• 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. doi: 10.1200/JCO.1999.17.5.1474.

  PMID: 10334533 RESULT

• Musgrove EA, Sutherland RL. Biological determinants of endocrine resistance in breast cancer. Nat Rev Cancer. 2009 Sep;9(9):631-43. doi: 10.1038/nrc2713.

  PMID: 19701242 RESULT

• 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. doi: 10.1016/s0960-0760(01)00149-2.

  PMID: 11850213 RESULT

• 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. doi: 10.1158/1078-0432.CCR-05-2127.

  PMID: 16467120 RESULT

• Konstantinidou AE, Korkolopoulou P, Patsouris E. Apoptotic markers for tumor recurrence: a minireview. Apoptosis. 2002 Oct;7(5):461-70. doi: 10.1023/a:1020091226673.

  PMID: 12207179 RESULT

• 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. doi: 10.1093/jnci/djn309. Epub 2008 Sep 23.

  PMID: 18812550 RESULT

• 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. doi: 10.1093/annonc/mdi352. Epub 2005 Jun 24.

  PMID: 15980158 RESULT

• Dowsett M. Biomarker investigations from the ATAC trial: the role of TA01. Breast Cancer Res Treat. 2004;87 Suppl 1:S11-8. doi: 10.1007/s10549-004-1578-3.

  PMID: 15597216 RESULT

• 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. doi: 10.1200/JCO.2005.07.559. Epub 2005 Mar 14.

  PMID: 15767642 RESULT

• 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.

  PMID: 15701892 RESULT

• Ellis MJ, Ma C. Letrozole in the neoadjuvant setting: the P024 trial. Breast Cancer Res Treat. 2007;105 Suppl 1(Suppl 1):33-43. doi: 10.1007/s10549-007-9701-x. Epub 2007 Oct 3.

  PMID: 17912634 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Anastrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Andre Mattar, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: BASIC SCIENCE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 17, 2009
• First Posted: November 19, 2009
• Study Start: April 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: June 1, 2008
• Last Updated: November 19, 2009

Record last verified: 2009-11

Locations

BR (1)