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

March 16, 2026 updated by: Centre Oscar Lambret

A Prospective, Randomized, Open-label, Multicenter Study Evaluating the Effects on Cognitive Functions of Adjuvant Endocrine Therapy in Postmenopausal Women With Breast Cancer.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Rennes, France
        • Centre Eugene Marquis
      • Strasbourg, France
        • Centre Paul Strauss

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: letrozole
Given orally
Drug: anastrozole
Given orally
Drug: exemestane
Given orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in verbal episodic memory performance after 6 months of treatment, using the Rey Auditory Verbal Learning Test
Time Frame: From baseline to 6 months of treatment
From baseline to 6 months of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in other cognitive functions at 6 and 12 months of treatment
Time Frame: From baseline to 6 and 12 months of treatment
From baseline to 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)
Time Frame: From baseline to 6 and 12 months of treatment
From baseline to 6 and 12 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Investigators

  • Principal Investigator: Emilie Le Rhun, Centre Oscar Lambret

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2009

Primary Completion (Actual)

April 4, 2012

Study Completion (Actual)

November 26, 2014

Study Registration Dates

First Submitted

May 2, 2009

First Submitted That Met QC Criteria

May 2, 2009

First Posted (Estimated)

May 5, 2009

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MNEMOSYNE-0712
  • 2008-003620-32 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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