Endometrial Changes in Breast Cancer Women With or Without Hormonal Therapies (BETA-1)
Evaluation of 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Tamoxifen users
Women undergoing therapy with Tamoxifen after surgery for breast cancer.
|
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
|
|
No treatment
Women who did not undergo any hormonal therapy after surgery for breast cancer.
|
Diagnostic hysteroscopy and targeted endometrial biopsy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Endometrial pathologies
Time Frame: 5 years after breast cancer surgery
|
Rate of endometrial pathologies (benign or malignant)
|
5 years after breast cancer surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Benito Chiofalo, M.D., "Regina Elena" National Cancer Institute of Rome
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BETA-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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