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Endometrial Changes in Breast Cancer Women With or Without Hormonal Therapies (BETA-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03898947
Recruitment Status : Completed
First Posted : April 2, 2019
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Antonio Simone Laganà, Università degli Studi dell'Insubria

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.


Condition or disease Intervention/treatment
Breast Cancer Endometrial Cancer Procedure: Diagnostic hysteroscopy and targeted endometrial biopsy

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Study Type : Observational
Actual Enrollment : 1329 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of Endometrial Changes in Breast Cancer Women With or Without Hormonal Therapies
Actual Study Start Date : January 2007
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Tamoxifen users
Women undergoing therapy with Tamoxifen after surgery for breast cancer.
Procedure: Diagnostic hysteroscopy and targeted endometrial biopsy
Diagnostic hysteroscopy and targeted endometrial biopsy

Aromatase inhibitors
Women undergoing therapy with Aromatase Inhibitors after surgery for breast cancer.
Procedure: Diagnostic hysteroscopy and targeted endometrial biopsy
Diagnostic hysteroscopy and targeted endometrial biopsy

No treatment
Women who did not undergo any hormonal therapy after surgery for breast cancer.
Procedure: Diagnostic hysteroscopy and targeted endometrial biopsy
Diagnostic hysteroscopy and targeted endometrial biopsy




Primary Outcome Measures :
  1. Endometrial pathologies [ Time Frame: 5 years after breast cancer surgery ]
    Rate of endometrial pathologies (benign or malignant)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Breast cancer women with or without hormonal therapy, undergoing diagnostic hysteroscopy and targeted endometrial biopsy.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898947


Sponsors and Collaborators
Università degli Studi dell'Insubria
Investigators
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Principal Investigator: Benito Chiofalo, M.D. "Regina Elena" National Cancer Institute of Rome
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Antonio Simone Laganà, Principal Investigator, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT03898947    
Other Study ID Numbers: BETA-1
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Antonio Simone Laganà, Università degli Studi dell'Insubria:
Tamoxifen
Aromatase inhibitors
Breast cancer
Endometrial cancer
Endometrial pathologies
Additional relevant MeSH terms:
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Breast Neoplasms
Endometrial Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases
Genital Diseases, Female