Endometrial Malignancy in Breast Cancer Patients With or Without AUB

Study Overview
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Brief Summary
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In order to assess the hysteroscopic, histopathologic, and ultrasonographic aspects of uterine monitoring in postmenopausal breast cancer patients with or without abnormal uterine bleeding (AUB), as well as to calculate the risk of endometrial cancer in women with or without AUB.

Detailed Description
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20-25% of postmenopausal women undergoing tamoxifen (TAM) therapy develop polyps, according to recent studies. Many large (>2 cm) and molecularly changed uterine polyps are usually seen in these women. Furthermore, a number of studies have demonstrated that TAM therapy raises the risk of endometrial cancer in both premenopausal and postmenopausal women. Studies suggest that women who use TAM may also have an increase in the prevalence of uterine sarcomas. In addition, the duration of TAM administration appears to increase the risk of endometrial cancer and uterine sarcoma. This multicentric cohort study will compare the ultrasonographic, hysteroscopic, and histopathologic findings in postmenopausal women treated for breast cancer with or without AUB in order to increase the robustness of a still ambiguous literature on the subject. It will estimate the risk of endometrial cancer in women with AUB according to various covariates related to the breast neoplasm or the ultrasonographic and hysteroscopic features.

Official Title
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Ultrasonographic, Hysteroscopic, Histopathologic Findings and Risk of Endometrial

Conditions
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Endometrial Neoplasms

Intervention / Treatment
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* Diagnostic Test: Ultrasound
* Diagnostic Test: Hysteroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In case of AUB: ultrasonographic endometrial thickness >5 mm at transvaginal ultrasound In case of non-AUB group ultrasonographic suspicion of endometrial or myometrial abnormalities Exclusion Criteria: severe comorbidities (cardiovascular, metabolic, endocrine, and immunological disorders) receiving any other form of pharmacologic therapy

Ages Eligible for Study
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Minimum Age: 43 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast cancer patients with abnormal uterine bleeding<br>Transvaginal ultrasonography Outpatient Hysteroscopy | Diagnostic Test: Ultrasound<br>* Transvaginal ultrasound to carry out uterine surveillance<br>Diagnostic Test: Hysteroscopy<br>* Outpatient hysteroscopy to carry out uterine surveillance<br>|
| Breast cancer patients without abnormal uterine bleeding<br>Transvaginal ultrasonography Outpatient Hysteroscopy | Diagnostic Test: Ultrasound<br>* Transvaginal ultrasound to carry out uterine surveillance<br>Diagnostic Test: Hysteroscopy<br>* Outpatient hysteroscopy to carry out uterine surveillance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endometrial cancer rate |  | 1 month after admission | 
| Endometrial hyperplasia rate |  | 1 month after admission |