Endometrial Changes in Breast Cancer Women With or Without Hormonal Therapies

Completed

• Conditions: Endometrial Cancer; Breast Cancer
• Interventions: Procedure: Diagnostic hysteroscopy and targeted endometrial biopsy

• Registration Number: NCT03898947
• Lead Sponsor: Università degli Studi dell'Insubria

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2016-12
• Study First Submitted: 2019-03-30
• Study First Submitted QC: 2019-04-01
• Study First Posted: 2019-04-02
• Study Completion: 2019-12
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1329

Inclusion Criteria

• History of breast cancer treated with surgery (regardless of the adjuvant radio/chemotherapy)

Exclusion Criteria

• Incomplete data collection
• Recurrence of breast cancer
• Any other concomitant disease
• Any pharmacological treatment (wash-out: 3 months) other than Tamoxifen or Aromatase inhibitors
• Women who switched from a therapy to another one during the study period.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No treatment	Diagnostic hysteroscopy and targeted endometrial biopsy	Women who did not undergo any hormonal therapy after surgery for breast cancer.
Tamoxifen users	Diagnostic hysteroscopy and targeted endometrial biopsy	Women undergoing therapy with Tamoxifen after surgery for breast cancer.
Aromatase inhibitors	Diagnostic hysteroscopy and targeted endometrial biopsy	Women undergoing therapy with Aromatase Inhibitors after surgery for breast cancer.

Primary Outcome Measures

Name	Time	Method
Endometrial pathologies	5 years after breast cancer surgery	Rate of endometrial pathologies (benign or malignant)