Clinical trial · Interventional
Letrozole, Anastrozole, Exemestane, or Tamoxifen Citrate in Treating Postmenopausal Women With Breast Cancer
A Prospective, Randomized, Open-label, Multicenter Study Evaluating the Effects on Cognitive Functions of Adjuvant Endocrine Therapy in Postmenopausal Women With Breast Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anastrozole | Drug | Anastrozole | ALIAS |
| exemestane | Drug | Exemestane | ALIAS |
| letrozole | Drug | Letrozole | ALIAS |
| tamoxifen citrate | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral tamoxifen citrate once daily for 1 year in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: tamoxifen citrate
- type
- EXPERIMENTAL
- label
- Arm II
- 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.
- interventionNames
- Drug: anastrozole
- Drug: exemestane
- Drug: letrozole
Primary outcomes (1)
- measure
- Changes in verbal episodic memory performance after 6 months of treatment, using the Rey Auditory Verbal Learning Test
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available