Clinical trial · Observational
The Effect of Aromatase Inhibitors on Cardiovascular Risk Factors in Women With Breast Cancer
NCT01080170CI-TRIAL-00022137SilhouettecompletedClinicalTrials.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)
This study explores how aromatase inhibitor therapy affects risk factors for heart disease 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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Anastrazole
- description
- Newly diagnosed, non-metastatic, hormone-receptor positive breast cancer patients, who have undergone lumpectomy, have been advised to not require chemotherapy, but will need to undergo radiation therapy and will be initiating therapy with anastrazole.
- label
- Control group - 2
- description
- Healthy controls.
Primary outcomes (1)
- measure
- Body Composition
- timeFrame
- 12 months
Secondary outcomes (1)
- measure
- Lipids
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 60 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Ambulatory women (aged 60-75), with a new diagnosis of nonmetastatic, hormone-receptor positive breast cancer, having undergone lumpectomy. They will not need chemotherapy and will have been prescribed but not yet started anastrazole. All will need a course of radiation therapy as part of usual care. Participants are instructed not to change their physical activity or eating habits over the period of the study. Comparisons are: * Identical to the cases except they are hormone-receptor negative and don't need hormonal therapy. * Healthy controls. Exclusion Criteria: * Nicotine usage * Metastatic breast cancer * Need for chemotherapy * AI other than anastrazole * Usage of steroids (equivalent of equal then or more than 7.5 mg prednisone x 3 months) * Clinically significant abnormality of thyroid function * Treatment with gonadal hormone replacement therapy within last 3 years * Status post unilateral/bilateral surgical oophorectomy * Having experienced a medical event, which may confound study outcomes \[e.g. heart attack, stroke, cancer (metastatic or newly diagnosed within last 5 years, except for non-melanoma skin cancer and breast), lupus, rheumatoid arthritis, chronic inflammatory disease\] * Medication-dependent diabetes mellitus or hypercholesterolemia. * Gastric surgery * Weight loss medication (prescription or over the counter)
References
Publications (0)
Data not yet available
No reference posted for this study.