NCT03898947

Endometrial Changes in Breast Cancer Women With or Without Hormonal Therapies

Evaluation of Endometrial Changes in Breast Cancer Women With or Without Hormonal Therapies

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,329 (actual)
• Sponsor: Università degli Studi dell'Insubria · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: —

Summary

A history of breast cancer is a risk factor for the development of endometrial pathologies, such as typical and atypical glandular hyperplasia, endometrial polyps, uterine fibroids, endometrial adenocarcinoma and uterine sarcoma, probably due to some common risk factors (eg. obesity, nulliparity). Even if ethiopathogenesis for breast cancer and endometrial pathologies is not well established, both genetic factors and hyperestrogenic state may be play a pivotal role for their development. Indeed, relative hyperestrogenism is also the main target for the treatment of breast cancer. Currently used therapies for this purpose are selective estrogen receptor (ER) modulators (SERMs), such as Tamoxifen (TAM), and third generation non-steroidal aromatase inhibitors (AIs), such as letrozole and anastrozole. TAM has both agonist and antagonist properties, depending upon the individual target organ and circulating levels of serum estrogens: on the one hand, it blocks estrogen stimulation in breast tissue; on the other hand, TAM shows an ER agonist activity in the endometrium that is able to stimulate proliferation and, in some cases, it causes an increased risk of uterine pathologies. Women with hormone-dependent breast cancer have to use TAM for five to ten years. Many reports suggest that the risk of uterine pathologies increases with the time of administration. Considering these elements, the primary aim of this study will be to investigate the incidence of endometrial pathologies, especially of endometrial cancer, in different groups of breast cancer women undergoing diagnostic hysteroscopy.

Conditions

• Breast Cancer
• Endometrial Cancer

Interventions

Type	Name	Description
PROCEDURE	Diagnostic hysteroscopy and targeted endometrial biopsy	Diagnostic hysteroscopy and targeted endometrial biopsy

Timeline

• Start date: 2007-01-01
• Primary completion: 2016-12-01
• Completion: 2019-12-01
• First posted: 2019-04-02
• Last updated: 2020-03-25