Skip to main content
OpenTrials
Completed

NCT Number: NCT03898947

Endometrial Changes in Breast Cancer Women With or Without Hormonal Therapies

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diagnostic hysteroscopy and targeted endometrial biopsy

Procedure

Diagnostic hysteroscopy and targeted endometrial biopsy

Primary outcomes

  1. Endometrial pathologies

    Time frame: 5 years after breast cancer surgery

    Rate of endometrial pathologies (benign or malignant)

Sponsors and collaborators

Lead sponsor

Università degli Studi dell'Insubria

Other

Registry information

Official study title

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

Acronym: BETA-1

Important dates

Study start
2007
Primary completion
2016
Study completion
2019
First posted
Apr 2, 2019
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.