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Endometrial Malignancy in Breast Cancer Patients With or Without AUB

Ultrasonographic, Hysteroscopic, Histopathologic Findings and Risk of Endometrial

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05977829
Acronym
TamAUB
Enrollment
283
Registered
2023-08-04
Start date
2020-01-01
Completion date
2022-07-30
Last updated
2023-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Neoplasms

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTUltrasound

Transvaginal ultrasound to carry out uterine surveillance

DIAGNOSTIC_TESTHysteroscopy

Outpatient hysteroscopy to carry out uterine surveillance

Sponsors

University of Campania Luigi Vanvitelli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
43 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Endometrial cancer rate1 month after admission
Endometrial hyperplasia rate1 month after admission

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026