Letrozole, Anastrozole, Exemestane, or Tamoxifen Citrate in Treating Postmenopausal Women With Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00893061
First received: May 2, 2009
Last updated: January 20, 2011
Last verified: July 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


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: February 2009
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral tamoxifen citrate once daily for 1 year in the absence of disease progression or unacceptable toxicity.
Drug: tamoxifen citrate
Given orally
Experimental: 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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Centre Oscar Lambret
Investigators
Principal Investigator: Emilie Le Rhun Centre Oscar Lambret
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00893061     History of Changes
Other Study ID Numbers: CDR0000635986, COL-MNEMOSYNE, 2007-12, INCA-RECF0899, EUDRACT-2008-003620-32
Study First Received: May 2, 2009
Last Updated: January 20, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
estrogen receptor-positive breast cancer
progesterone receptor-positive breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Citric Acid
Tamoxifen
Anastrozole
Exemestane
Letrozole
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents
Aromatase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 18, 2014