Clinical trial · Observational
Effect of Aromatase Inhibitor Therapy on Blood Vessel Function in Postmenopausal Women With Breast Cancer
Effect of Aromatase Inhibitor Therapy for Breast Cancer on Endothelial Function
NCT00719966CI-TRIAL-00072651completedClinicalTrials.gov clinicaltrialsProvenance
- 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: Aromatase inhibitor therapy is used in treating postmenopausal women who have hormone-dependent breast cancer. It is not yet known what effect aromatase inhibitor therapy has on blood vessel function. PURPOSE: This clinical trial is studying the effect of aromatase inhibitor therapy on blood vessel function in 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 |
| assessment of therapy complications | Procedure | — | UNRESOLVED |
| exemestane | Drug | Exemestane | ALIAS |
| letrozole | Drug | Letrozole | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Group 1 (hormone receptor-positive)
- description
- Patients receive aromatase inhibition therapy for up to 6 months in the absence of unacceptable toxicity.
- interventionNames
- Drug: anastrozole
- Drug: exemestane
- Drug: letrozole
- Procedure: assessment of therapy complications
- label
- Group 2 (hormone receptor-negative)
- description
- Patients do not receive adjuvant treatment.
- interventionNames
- Procedure: assessment of therapy complications
Primary outcomes (1)
- measure
- Endothelial dysfunction as a result of aromatase inhibitor therapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of breast cancer * Ductal carcinoma in situ (DCIS) allowed provided the patient will not receive tamoxifen as part of treatment for their cancer * May not have had a prior mastectomy with requirement for mastectomy of the contralateral breast * No requirement for axillary lymph node dissection with a history of contralateral mastectomy and/or contralateral axillary lymph node dissection * Hormone receptor status meeting 1 of the following criteria: * Hormone receptor negative and not eligible for aromatase inhibitor therapy (AI) * Hormone receptor positive and are not receiving an AI PATIENT CHARACTERISTICS: * Postmenopausal * No known or symptomatic coronary artery disease * No significant co-morbidities, including any of the following conditions: * Active renal or hepatic disease * Known uncontrolled and/or untreated peripheral arterial disease * Uncontrolled and/or untreated hypertension * Uncontrolled and/or untreated diabetes * Uncontrolled and/or untreated hyperlipidemia PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 7 days since prior hormone replacement therapy or hormone-based contraception * More than 12 months since prior and no concurrent tamoxifen or aromatase inhibitor therapy for this disease * More than 12 months since prior and no concurrent chemotherapy for this disease * No prior bilateral mastectomy
References
Publications (0)
Data not yet available
No reference posted for this study.