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

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ClinicalTrials.gov Identifier: NCT01016665
Recruitment Status : Completed
First Posted : November 19, 2009
Last Update Posted : November 19, 2009
Sponsor:
Information provided by:
Federal University of São Paulo

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Anastrozole Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Basic Science
Official Title: Anastrozole Reduced Proliferation and Progesterone Receptor Indexes in Short Term Hormone Therapy. A Prospective Placebo Double Blind Study
Study Start Date : April 2005
Actual Primary Completion Date : July 2007
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Drug: Anastrozole
Tamoxifen 20mg and anastrozole 1 mg
Tamoxifen
Tamoxifen 20 mg day 26 days
Drug: Anastrozole
Tamoxifen 20mg and anastrozole 1 mg
Anastrozole
Anastrozole 1mg 26 days
Drug: Anastrozole
Tamoxifen 20mg and anastrozole 1 mg



Primary Outcome Measures :
  1. Expression of progesterone [ Time Frame: end of the study (june 2008) ]

Secondary Outcome Measures :
  1. Expression of Ki-67 [ Time Frame: end of the study (june 2008) ]


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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01016665


Locations
Brazil
Sao Paulo Federal University
Sao Paulo, Brazil, 01530020
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Andre Mattar, MD

Publications of Results:

Other Publications:
Responsible Party: Andre Mattar MD, Federal University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01016665     History of Changes
Other Study ID Numbers: 0904/04
First Posted: November 19, 2009    Key Record Dates
Last Update Posted: November 19, 2009
Last Verified: November 2009

Keywords provided by Federal University of São Paulo:
Breast cancer
Short Term
Homontherapy
aromatase inhibitor
Short term hormonetherapy in breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Progesterone
Tamoxifen
Anastrozole
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Progestins
Estrogen Antagonists
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action