Endometrial Changes in Breast Cancer Women.

Active, not recruiting

• Conditions: Endometrial Cancer; Endometrial Hyperplasia With Atypia; Breast Cancer; TAM
• Interventions: Diagnostic Test: Hysteroscopy

• Registration Number: NCT05717634
• Lead Sponsor: Regina Elena Cancer Institute

Brief Summary

This is a prospective observational multicentric study. The aim is to evaluate the incidence of endometrial cancer and endometrial atypical hyperplasia in patients with previous breast cancer, treated with different adjuvant therapies. The second aim is to identify ultrasonographic soft markers related with endometrial cancer or atipycal hyperplasia.

Detailed Description

This is a prospective observational multicentric study. Patient with a history of breast cancer treated with adjuvant hormonal therapies or with no therapies, will be enrolled and followed once a year with physical exam and endovaginal ultrasound. Patients with suspected endometrial pathology will undergo hysteroscopy with endometrial biopsy or endometrial lesion resection.

The aim is to evaluate the incidence of endometrial cancer and endometrial atypical hyperplasia in patients with previous breast cancer, treated with different adjuvant therapies. The second aim is to identify ultrasonographic soft markers related with endometrial cancer or atipycal hyperplasia.

Study Timeline

• Status Verified: 2023-01
• Study Start: 2023-01-26
• Study First Submitted: 2023-01-29
• Study First Submitted QC: 2023-01-29
• Last Update Submitted: 2023-01-29
• Study First Posted: 2023-02-08
• Last Update Posted: 2023-02-08
• Primary Completion: 2023-09-26
• Study Completion: 2024-01-26

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 829

Inclusion Criteria

• Personal history of breast cancer

Exclusion Criteria

• Personal history of other hormonal sensitive cancers
• Assumption of hormones in the previous 5 years
• Previous medical assisted reproduction technique
• Lynch syndrome or BRCA 1/2 mutations

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TAM	Hysteroscopy	Patients with previous breast cancer with hormonal receptor expression that are treated with tamoxifen.
Ais	Hysteroscopy	Patients with previous breast cancer with hormonal receptor expression that are treated with Ais.
No Therapy	Hysteroscopy	Patients with previous breast cancer that are not treated with none hormonal therapies.

Primary Outcome Measures

Name	Time	Method
Incidence of endometrial cancer	One year	Evaluation of the incidence of endometrial cancer and atypical hyperplasya

Secondary Outcome Measures

Name	Time	Method
Ultrasonographic soft markers of endometrial pathology	One year	Identification of ultrasonographic soft markers of endometrial pathology

Trial Locations

Locations (1)

IRCCS "Regina Elena" National Cancer Institute; 🇮🇹 Rome, Lazio, Italy