Breast CancerNCT01016665
Anastrozole Reduced Proliferation and Progesterone Receptor Indexes in Short Term Hormone Therapy
A study testing Anastrozole in people with Breast Cancer, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Anastrozole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2005to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Invasive breast cancer post-menopausal women
- Estrogen and/or progesterone receptor positive
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anastrozole Reduced Proliferation and Progesterone Receptor Indexes in Short Term Hormone Therapy. A Prospective Placebo Double Blind Study
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
- Being tested
- Anastrozole
- Keywords
- Breast cancer, Short Term, Homontherapy, aromatase inhibitor, Short term hormonetherapy in breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnastrozoleDrug
Tamoxifen 20mg and anastrozole 1 mg
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Anastrozole |
| Tamoxifen | Other | Tamoxifen 20 mg day 26 days Receives: Drug: Anastrozole |
| Anastrozole | Other | Anastrozole 1mg 26 days Receives: Drug: Anastrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of progesterone
Measured: end of the study (june 2008)
Secondary outcomes (1)
Expression of Ki-67
Measured: end of the study (june 2008)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2009 (estimated)
- Study startApr 2005
- Primary completionJul 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Andre Mattar, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016665
- Sponsor's protocol ID
- 0904/04
- Status last verified
- Nov 2009
- First submitted
- 17 Nov 2009
- Last updated
- 19 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12559863Early 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.
PubMed 15894097Macaskill 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.
PubMed 17110627Dowsett M. Preoperative models to evaluate endocrine strategies for breast cancer. Clin Cancer Res. 2003 Jan;9(1 Pt 2):502S-10S.
PubMed 12538507Dixon 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.
PubMed 10873072Harvey 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.
PubMed 10334533Musgrove EA, Sutherland RL. Biological determinants of endocrine resistance in breast cancer. Nat Rev Cancer. 2009 Sep;9(9):631-43. doi: 10.1038/nrc2713.
PubMed 19701242Miller 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.
PubMed 11850213Dowsett 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.
PubMed 16467120Konstantinidou AE, Korkolopoulou P, Patsouris E. Apoptotic markers for tumor recurrence: a minireview. Apoptosis. 2002 Oct;7(5):461-70. doi: 10.1023/a:1020091226673.
PubMed 12207179Ellis 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.
PubMed 18812550Colozza 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.
PubMed 15980158Dowsett 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.
PubMed 15597216Dowsett 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.
PubMed 15767642Dowsett 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.
PubMed 15701892
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anastrozole Reduced Proliferation and Progesterone Receptor Indexes in Short Term Hormone Therapy. A Prospective Placebo Double Blind Study
- ClinicalTrials.gov ID
- NCT01016665
- Acronym / sponsor ID
- 0904/04
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Short Term, Homontherapy, aromatase inhibitor, Short term hormonetherapy in breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 19 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: AnastrozolePlacebo |
| Tamoxifen | Other | Drug: AnastrozoleTamoxifen 20 mg day 26 days |
| Anastrozole | Other | Drug: AnastrozoleAnastrozole 1mg 26 days |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Invasive breast cancer post-menopausal women
- Estrogen and/or progesterone receptor positive
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnastrozoleTamoxifen 20mg and anastrozole 1 mg | Drug | Anastrozole, Placebo, Tamoxifen |
Primary outcome
Expression of progesterone
Time frame: end of the study (june 2008)
1 secondary outcome
Expression of Ki-67
Time frame: end of the study (june 2008)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2009.
- Background: PubMed 12559863Cuzick 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 publication: PubMed 15894097Early 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 publication: PubMed 17110627Macaskill 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 publication: PubMed 12538507Dowsett M. Preoperative models to evaluate endocrine strategies for breast cancer. Clin Cancer Res. 2003 Jan;9(1 Pt 2):502S-10S.
- Results publication: PubMed 10873072Dixon 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 publication: PubMed 10334533Harvey 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 publication: PubMed 19701242Musgrove 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 publication: PubMed 11850213Miller 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 publication: PubMed 16467120Dowsett 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 publication: PubMed 12207179Konstantinidou 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 publication: PubMed 18812550Ellis 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 publication: PubMed 15980158Colozza 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andre Mattar, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anastrozole in people with Breast Cancer, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of progesterone (time frame: end of the study (june 2008)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01016665, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2009.