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
1329
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