Status:
COMPLETED
Letrozole, Anastrozole, Exemestane, or Tamoxifen Citrate in Treating Postmenopausal Women With Breast Cancer
Lead Sponsor:
Centre Oscar Lambret
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
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 bo...
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 cog...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
March 16 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 26 2014
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00893061
Start Date
March 16 2009
End Date
November 26 2014
Last Update
June 14 2024
Active Locations (3)
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1
Centre Oscar Lambret
Lille, France, 59020
2
Centre Eugene Marquis
Rennes, France
3
Centre Paul Strauss
Strasbourg, France