Skip to content

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03898947
Acronym
BETA-1
Enrollment
1329
Registered
2019-04-02
Start date
2007-01-31
Completion date
2019-12-31
Last updated
2020-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Endometrial Cancer

Keywords

Tamoxifen, Aromatase inhibitors, Breast cancer, Endometrial cancer, Endometrial pathologies

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.

Interventions

PROCEDUREDiagnostic hysteroscopy and targeted endometrial biopsy

Diagnostic hysteroscopy and targeted endometrial biopsy

Sponsors

Università degli Studi dell'Insubria
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Endometrial pathologies5 years after breast cancer surgeryRate of endometrial pathologies (benign or malignant)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026