NCT00893061

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at below P25 for phase_3 breast-cancer

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 5, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2012

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2014

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

3.1 years

First QC Date

May 2, 2009

Last Update Submit

March 16, 2026

Conditions

Breast Cancer

Keywords

stage IA breast cancerstage IB breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerestrogen receptor-positive breast cancerprogesterone receptor-positive breast cancer

Outcome Measures

Primary Outcomes (1)

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

    From baseline to 6 months of treatment

Secondary Outcomes (2)

  • Changes in other cognitive functions at 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)

    From baseline to 6 and 12 months of treatment

Study Arms (2)

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

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: anastrozoleDrug: exemestaneDrug: letrozole

Interventions

anastrozoleDRUG

Given orally

Arm II
exemestaneDRUG

Given orally

Arm II
letrozoleDRUG

Given orally

Arm II
tamoxifen citrateDRUG

Given orally

Arm I

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Eugene Marquis

Rennes, France

Location

Centre Paul Strauss

Strasbourg, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

AnastrozoleexemestaneLetrozoleTamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Emilie Le Rhun

    Centre Oscar Lambret

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2009

First Posted

May 5, 2009

Study Start

March 16, 2009

Primary Completion

April 4, 2012

Study Completion

November 26, 2014

Last Updated

March 17, 2026

Record last verified: 2026-03

Locations

FR(3)