Letrozole, Anastrozole, Exemestane, or Tamoxifen Citrate in Treating Postmenopausal Women With Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
anastrozole
exemestane
letrozole
tamoxifen citrate
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring 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
Eligibility 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)
Sites / Locations
- Centre Oscar LambretRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm I
Arm II
Arm Description
Patients receive oral tamoxifen citrate once daily for 1 year in the absence of disease progression or unacceptable toxicity.
Patients receive an oral aromatase inhibitor (letrozole, anastrozole, or exemestane) once daily for 1 year in the absence of disease progression or unacceptable toxicity.
Outcomes
Primary Outcome Measures
Changes in verbal episodic memory performance after 6 months of treatment, using the Rey Auditory Verbal Learning Test
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00893061
Brief Title
Letrozole, Anastrozole, Exemestane, or Tamoxifen Citrate in Treating Postmenopausal Women With Breast Cancer
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
July 2010 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Centre Oscar Lambret
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive oral tamoxifen citrate once daily for 1 year in the absence of disease progression or unacceptable toxicity.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients receive an oral aromatase inhibitor (letrozole, anastrozole, or exemestane) once daily for 1 year in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
anastrozole
Intervention Description
Given orally
Intervention Type
Drug
Intervention Name(s)
exemestane
Intervention Description
Given orally
Intervention Type
Drug
Intervention Name(s)
letrozole
Intervention Description
Given orally
Intervention Type
Drug
Intervention Name(s)
tamoxifen citrate
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
Changes in verbal episodic memory performance after 6 months of treatment, using the Rey Auditory Verbal Learning Test
Secondary Outcome Measure Information:
Title
Changes in other cognitive functions at 6 and 12 months of treatment
Title
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)
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilie Le Rhun
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilie Le Rhun
Phone
33-32-029-5959
12. IPD Sharing Statement
Learn more about this trial
Letrozole, Anastrozole, Exemestane, or Tamoxifen Citrate in Treating Postmenopausal Women With Breast Cancer
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