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Sponsored by: |
National Cancer Institute, France |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00893061 |
RATIONALE: Estrogen can cause the growth of breast cancer cells. Aromatase inhibitors, such as letrozole, anastrozole, and exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. It is not yet known whether aromatase inhibitors or tamoxifen citrate have less effect on memory in patients receiving treatment for breast cancer.
PURPOSE: This randomized phase III trial is studying letrozole, anastrozole, or exemestane to see how they effect memory compared with tamoxifen citrate in treating postmenopausal women with breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: anastrozole Drug: exemestane Drug: letrozole Drug: tamoxifen citrate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | A Prospective, Randomized, Open-Label, Multicenter Study Evaluating the Effects on Cognitive Functions of Adjuvant Endocrine Therapy in Postmenopausal Women With Breast Cancer. |
Estimated Enrollment: | 60 |
Study Start Date: | November 2008 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive oral tamoxifen citrate once daily for 1 year in the absence of disease progression or unacceptable toxicity.
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Drug: tamoxifen citrate
Given orally
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Arm II: Experimental
Patients receive an oral aromatase inhibitor (letrozole, anastrozole, or exemestane) once daily for 1 year in the absence of disease progression or unacceptable toxicity.
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Drug: anastrozole
Given orally
Drug: exemestane
Given orally
Drug: letrozole
Given orally
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed for 1 year.
Ages Eligible for Study: | up to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
France | |
Centre Oscar Lambret | Recruiting |
Lille, France, 59020 | |
Contact: Emilie Le Rhun 33-32-029-5959 |
Principal Investigator: | Emilie Le Rhun | Centre Oscar Lambret |
Study ID Numbers: | CDR0000635986, INCA-MNEMOSYNE, 2007-12, RECF0899, EUDRACT-2008-003620-32 |
Study First Received: | May 2, 2009 |
Last Updated: | May 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00893061 History of Changes |
Health Authority: | Unspecified |
stage I breast cancer stage II breast cancer stage IIIA breast cancer |
stage IIIB breast cancer estrogen receptor-positive breast cancer progesterone receptor-positive breast cancer |
Estrogen Antagonists Anastrozole Estrogens Skin Diseases Progesterone Antineoplastic Agents, Hormonal Hormone Antagonists Citric Acid Hormones, Hormone Substitutes, and Hormone Antagonists Adjuvants, Immunologic |
Breast Neoplasms Bone Density Conservation Agents Letrozole Selective Estrogen Receptor Modulators Hormones Tamoxifen Estrogen Receptor Modulators Exemestane Aromatase Inhibitors Breast Diseases |
Estrogen Antagonists Anastrozole Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms Enzyme Inhibitors Bone Density Conservation Agents |
Letrozole Selective Estrogen Receptor Modulators Tamoxifen Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Exemestane Aromatase Inhibitors Breast Diseases |