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

Anastrozole Reduced Proliferation and Progesterone Receptor Indexes in Short Term Hormone Therapy. A Prospective Placebo Double Blind Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01016665
Enrollment
71
Registered
2009-11-19
Start date
2005-04-30
Completion date
2008-06-30
Last updated
2009-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

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

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.

Interventions

DRUGAnastrozole

Tamoxifen 20mg and anastrozole 1 mg

Sponsors

Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Expression of progesteroneend of the study (june 2008)

Secondary

MeasureTime frame
Expression of Ki-67end of the study (june 2008)

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026