Endometrial Changes in Breast Cancer Women.

Regina Elena Cancer Institute

Status: Active, not recruiting

Conditions: Endometrial Cancer; Breast Cancer; TAM; Endometrial Hyperplasia With Atypia

Treatments: Diagnostic Test: Hysteroscopy

Study type: Observational

Funder types: Other

Identifiers

NCT05717634

Regina Elena

Details and patient eligibility

About

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.

Full 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.

Enrollment: 829 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

829 participants in 3 patient groups

TAM

Description:

Patients with previous breast cancer with hormonal receptor expression that are treated with tamoxifen.

Treatment:

Diagnostic Test: Hysteroscopy

Ais

Description:

Patients with previous breast cancer with hormonal receptor expression that are treated with Ais.

Treatment:

Diagnostic Test: Hysteroscopy

No Therapy

Description:

Patients with previous breast cancer that are not treated with none hormonal therapies.

Treatment:

Diagnostic Test: Hysteroscopy