Endometrial Changes in Breast Cancer Women With or Without Hormonal Therapies

NCT03898947 | Completed DMC

• 1 other identifier: BETA-1
• Study Type: observational
• Target: 1,329
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer; Endometrial Cancer

Keywords

Tamoxifen; Aromatase inhibitors; Breast cancer; Endometrial cancer; Endometrial pathologies

Outcome Measures

Primary Outcomes (1)

• Endometrial pathologies

  Rate of endometrial pathologies (benign or malignant)

  5 years after breast cancer surgery

Study Arms (3)

Tamoxifen users

Women undergoing therapy with Tamoxifen after surgery for breast cancer.

Procedure: 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

No treatment

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

Procedure: Diagnostic hysteroscopy and targeted endometrial biopsy

Interventions

Diagnostic hysteroscopy and targeted endometrial biopsy PROCEDURE

Diagnostic hysteroscopy and targeted endometrial biopsy

Aromatase inhibitors; No treatment; Tamoxifen users

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer women with or without hormonal therapy, undergoing diagnostic hysteroscopy and targeted endometrial biopsy.

You may qualify if:

• History of breast cancer treated with surgery (regardless of the adjuvant radio/chemotherapy)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

Related Publications (1)

• Chiofalo B, Mazzon I, Di Angelo Antonio S, Amadore D, Vizza E, Lagana AS, Vocaturo G, Calagna G, Favilli A, Palmara V, Maranto M, Vitale SG, Cucinella G, Granese R, Ghezzi F, Sperduti I, Triolo O. Hysteroscopic Evaluation of Endometrial Changes in Breast Cancer Women with or without Hormone Therapies: Results from a Large Multicenter Cohort Study. J Minim Invasive Gynecol. 2020 May-Jun;27(4):832-839. doi: 10.1016/j.jmig.2019.08.007. Epub 2019 Aug 16.

  PMID: 31425735 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Endometrial Neoplasms

Interventions

Hysteroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Benito Chiofalo, M.D.

  "Regina Elena" National Cancer Institute of Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 30, 2019
• First Posted: April 2, 2019
• Study Start: January 1, 2007
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2019
• Last Updated: March 25, 2020

Record last verified: 2020-03