Endometrial Changes in Breast Cancer Women With or Without Hormonal Therapies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1329 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Office Hysteroscopy in Infertility Work-out: the Role of Endometrial Hyperplasia in Southern Italian Women

NCT03965585

Infertility, Female Endometrial Hyperplasia PCOS

COMPLETED

Endometrial Malignancy in Breast Cancer Patients With or Without AUB

NCT05977829

Endometrial Neoplasms

COMPLETED

Endometrial Tissues and Mononuclear Cells Receptivity in Pathogenesis of Endometrial Proliferative Processes

NCT06115577

Endometrial Hyperplasia Without Atypia Endometrial Hyperplasia With Atypia Endometrial Cancer +4 more

COMPLETED

Second Laparoscopic Surgery for Recurrent Unilateral Endometriomas.

NCT02047838

Endometrioma Endometriosis Surgery

COMPLETED

Risk Factors for Hormonal Therapy Failure in Patients With Endometriosis.

NCT06510647

Endometriosis

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Endometrial Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tamoxifen users

Women undergoing therapy with Tamoxifen after surgery for breast cancer.

Diagnostic hysteroscopy and targeted endometrial biopsy

Intervention Type PROCEDURE

Diagnostic hysteroscopy and targeted endometrial biopsy

Aromatase inhibitors

Women undergoing therapy with Aromatase Inhibitors after surgery for breast cancer.

Diagnostic hysteroscopy and targeted endometrial biopsy

Intervention Type PROCEDURE

Diagnostic hysteroscopy and targeted endometrial biopsy

No treatment

Women who did not undergo any hormonal therapy after surgery for breast cancer.

Diagnostic hysteroscopy and targeted endometrial biopsy

Intervention Type PROCEDURE

Diagnostic hysteroscopy and targeted endometrial biopsy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Diagnostic hysteroscopy and targeted endometrial biopsy

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No