Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	Under 70	Other, Pharmaceutical / Industry	INCA-MNEMOSYNE MNEMOSYNE, 2007-12, RECF0899, EUDRACT-2008-003620-32, NCT00893061

Objectives

Primary

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

Secondary

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

Entry 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

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)

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

Expected Enrollment

Outcomes

Changes in verbal episodic memory performance after 6 months of treatment, using the Rey Auditory Verbal Learning Test

Changes in other cognitive functions at 6 and 12 months of treatment
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)

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.

Trial Contact Information

Trial Lead Organizations

Institut National du Cancer

Emilie Le Rhun, Principal investigator		Ph: 33-32-029-5959

France
	Lille
	Centre Oscar Lambret
		Emilie Le Rhun	Ph:  33-32-029-5959

Registry Information
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.
Trial Start Date		2008-11-26
Trial Completion Date		2010-07-31 (estimated)
Registered in ClinicalTrials.gov		NCT00893061
Date Submitted to PDQ		2009-02-18
Information Last Verified		2009-05-01