Endometrial Changes in Breast Cancer Women With or Without Hormonal Therapies

Brief Title

Endometrial Changes in Breast Cancer Women With or Without Hormonal Therapies

Official Title

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

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.

Study Type

Observational

Primary Outcome

Endometrial pathologies

Condition

Breast Cancer

Intervention

Diagnostic hysteroscopy and targeted endometrial biopsy

Study Arms / Comparison Groups

 Tamoxifen users

Description:  Women undergoing therapy with Tamoxifen after surgery for breast cancer.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

Start Date

January 2007

Completion Date

December 2019

Primary Completion Date

December 2016

Eligibility Criteria

        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.

Gender

Female

Ages

18 Years - 80 Years

Contacts

Benito Chiofalo, M.D., ,

Administrative Informations

NCT ID

NCT03898947

Organization ID

BETA-1

Responsible Party

Principal Investigator

Study Sponsor

Università degli Studi dell'Insubria

Study Sponsor

Benito Chiofalo, M.D., Principal Investigator, "Regina Elena" National Cancer Institute of Rome

Verification Date

March 2020