search
Back to results

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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Anastrozole
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Breast Cancer focused on measuring Breast cancer, Short Term, Homontherapy, aromatase inhibitor, Short term hormonetherapy in breast cancer

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sao Paulo Federal University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Other

Other

Arm Label

Placebo

Tamoxifen

Anastrozole

Arm Description

Placebo

Tamoxifen 20 mg day 26 days

Anastrozole 1mg 26 days

Outcomes

Primary Outcome Measures

Expression of progesterone

Secondary Outcome Measures

Expression of Ki-67

Full Information

First Posted
November 17, 2009
Last Updated
November 18, 2009
Sponsor
Federal University of São Paulo
search

1. Study Identification

Unique Protocol Identification Number
NCT01016665
Brief Title
Anastrozole Reduced Proliferation and Progesterone Receptor Indexes in Short Term Hormone Therapy
Official Title
Anastrozole Reduced Proliferation and Progesterone Receptor Indexes in Short Term Hormone Therapy. A Prospective Placebo Double Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Short Term, Homontherapy, aromatase inhibitor, Short term hormonetherapy in breast cancer

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Masking
Double
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Tamoxifen
Arm Type
Other
Arm Description
Tamoxifen 20 mg day 26 days
Arm Title
Anastrozole
Arm Type
Other
Arm Description
Anastrozole 1mg 26 days
Intervention Type
Drug
Intervention Name(s)
Anastrozole
Intervention Description
Tamoxifen 20mg and anastrozole 1 mg
Primary Outcome Measure Information:
Title
Expression of progesterone
Time Frame
end of the study (june 2008)
Secondary Outcome Measure Information:
Title
Expression of Ki-67
Time Frame
end of the study (june 2008)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre Mattar, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sao Paulo Federal University
City
Sao Paulo
ZIP/Postal Code
01530020
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
12559863
Citation
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.
Results Reference
background
PubMed Identifier
15894097
Citation
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.
Results Reference
result
PubMed Identifier
17110627
Citation
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.
Results Reference
result
PubMed Identifier
12538507
Citation
Dowsett M. Preoperative models to evaluate endocrine strategies for breast cancer. Clin Cancer Res. 2003 Jan;9(1 Pt 2):502S-10S.
Results Reference
result
PubMed Identifier
10873072
Citation
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.
Results Reference
result
PubMed Identifier
10334533
Citation
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.
Results Reference
result
PubMed Identifier
19701242
Citation
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.
Results Reference
result
PubMed Identifier
11850213
Citation
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.
Results Reference
result
PubMed Identifier
16467120
Citation
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.
Results Reference
result
PubMed Identifier
12207179
Citation
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.
Results Reference
result
PubMed Identifier
18812550
Citation
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.
Results Reference
result
PubMed Identifier
15980158
Citation
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.
Results Reference
result
PubMed Identifier
15597216
Citation
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.
Results Reference
result
PubMed Identifier
15767642
Citation
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.
Results Reference
result
PubMed Identifier
15701892
Citation
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.
Results Reference
result
PubMed Identifier
17912634
Citation
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. Erratum In: Breast Cancer Res Treat. 2008 Nov;112(2):371.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs