Full Text View
Tabular View
No Study Results Posted
Related Studies
Letrozole, Anastrozole, Exemestane, or Tamoxifen Citrate in Treating Postmenopausal Women With Breast Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), May 2009
First Received: May 2, 2009   No Changes Posted
Sponsored by: National Cancer Institute, France
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00893061
  Purpose

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
Breast Cancer
Drug: anastrozole
Drug: exemestane
Drug: letrozole
Drug: tamoxifen citrate
Phase III

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Memory
Drug Information available for: Tamoxifen Tamoxifen citrate Citric acid Exemestane Letrozole Anastrozole Sodium Citrate
U.S. FDA Resources
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.

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Changes in verbal episodic memory performance after 6 months of treatment, using the Rey Auditory Verbal Learning Test [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in other cognitive functions at 6 and 12 months of treatment [ Designated as safety issue: No ]
  • Psychological and social impact at 6 and 12 months of treatment, using the HADS scale and quality of life questionnaires (i.e., IADL and QLQ-C30) [ Designated as safety issue: No ]

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
Arm I: Experimental
Patients receive oral tamoxifen citrate once daily for 1 year in the absence of disease progression or unacceptable toxicity.
Drug: tamoxifen citrate
Given orally
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.
Drug: anastrozole
Given orally
Drug: exemestane
Given orally
Drug: letrozole
Given orally

Detailed Description:

OBJECTIVES:

Primary

  • To evaluate verbal episodic memory in patients with breast cancer after 6 months of treatment with aromatase inhibitors (AI) vs tamoxifen citrate.

Secondary

  • To evaluate cognitive functions of these patients at month 6 and 12 of treatment.
  • To evaluate the psychological and social impact on these patients at month 6 and 12 of treatment.

OUTLINE: This is a multicenter study.

Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral tamoxifen citrate once daily for 1 year in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive an oral aromatase inhibitor (letrozole, anastrozole, or exemestane) once daily for 1 year in the absence of disease progression or unacceptable toxicity. Patients undergo cognitive, psychological, social, and quality of life assessments every 6 months using the CDS scale, the Edinburgh Handedness Inventory, the Mini Mental Test, the French version of the National Adult Reading Test, the Benton Visual Retention test, the direct and indirect capacities of the WAIS-R, the WMS sequential visual-spatial capacity, the dual task test, categorical and formal verbal fluency, the Trail making test, the Stroop test, the Wisconsin Card Sorting test, the choice reaction time test, the sequential visual spatial capacity, the HADS scale, IADL, and QLQ-C30 questionnaires.

After completion of study treatment, patients are followed for 1 year.

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer
  • No metastatic disease
  • Meets criteria for initiating adjuvant endocrine therapy
  • Hormone receptor status:

    • Estrogen receptor- and/or progesterone receptor-positive disease

PATIENT CHARACTERISTICS:

  • Postmenopausal, defined as no menstruation for ≥ 1 year, confirmed by a measurement of FSH and 17-beta-estradiol
  • Karnofsky performance status 80-100%
  • Native speaker of French
  • Beneficiary of a French Social Security insurance plan
  • No prior cognitive disorders
  • No depression or other confirmed active psychiatric disease
  • Able to undergo the medical monitoring of the trial due to geographic, social or psychological reasons
  • No personal or family history of thromboembolic disease

PRIOR CONCURRENT THERAPY:

  • No prior adjuvant chemotherapy
  • No concurrent follow-up participation on another study
  • No concurrent treatment with psychotropic substances (i.e., long half life benzodiazepines, antipsychotics, anticholinesterase)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00893061

Locations
France
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Emilie Le Rhun     33-32-029-5959        
Sponsors and Collaborators
National Cancer Institute, France
Investigators
Principal Investigator: Emilie Le Rhun Centre Oscar Lambret
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009