Breast CancerBETA-1NCT03898947
Endometrial Changes in Breast Cancer Women With or Without Hormonal Therapies
An observational study of Breast Cancer and Endometrial Cancer, run by Università degli Studi dell'Insubria.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Endometrial Cancer
- What is being tested?
- Diagnostic hysteroscopy and targeted endometrial biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 1,329 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Adult, Older adult
Study population: Breast cancer women with or without hormonal therapy, undergoing diagnostic hysteroscopy and targeted endometrial biopsy.
Who may be able to join
- History of breast cancer treated with surgery (regardless of the adjuvant radio/chemotherapy)
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Breast Cancer, Endometrial Cancer
- Being tested
- Diagnostic hysteroscopy and targeted endometrial biopsy
- Keywords
- Tamoxifen, Aromatase inhibitors, Breast cancer, Endometrial cancer, Endometrial pathologies
- Medical subject headings
- Breast Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic hysteroscopy and targeted endometrial biopsyProcedure or surgery
Diagnostic hysteroscopy and targeted endometrial biopsy
| Study group | Role | What they receive |
|---|---|---|
| Tamoxifen users | Women undergoing therapy with Tamoxifen after surgery for breast cancer. Receives: Procedure: Diagnostic hysteroscopy and targeted endometrial biopsy | |
| Aromatase inhibitors | Women undergoing therapy with Aromatase Inhibitors after surgery for breast cancer. Receives: Procedure: Diagnostic hysteroscopy and targeted endometrial biopsy | |
| No treatment | Women who did not undergo any hormonal therapy after surgery for breast cancer. Receives: Procedure: Diagnostic hysteroscopy and targeted endometrial biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial pathologies
Rate of endometrial pathologies (benign or malignant)
Measured: 5 years after breast cancer surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study startJan 2007
- Primary completionDec 2016
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Simone Laganà, Università degli Studi dell'Insubria
- Investigators
- Benito Chiofalo, M.D., Principal investigator, "Regina Elena" National Cancer Institute of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898947
- Sponsor's protocol ID
- BETA-1
- Acronym
- BETA-1
- Status last verified
- Mar 2020
- First submitted
- 30 Mar 2019
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31425735
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Endometrial Changes in Breast Cancer Women With or Without Hormonal Therapies
- ClinicalTrials.gov ID
- NCT03898947
- Acronym / sponsor ID
- BETA-1 / BETA-1
- Conditions
- Breast Cancer, Endometrial Cancer
- Keywords
- Tamoxifen, Aromatase inhibitors, Breast cancer, Endometrial cancer, Endometrial pathologies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,329 participants (actual)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- Jan 2007 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tamoxifen users | – | Procedure: Diagnostic hysteroscopy and targeted endometrial biopsyWomen undergoing therapy with Tamoxifen after surgery for breast cancer. |
| Aromatase inhibitors | – | Procedure: Diagnostic hysteroscopy and targeted endometrial biopsyWomen undergoing therapy with Aromatase Inhibitors after surgery for breast cancer. |
| No treatment | – | Procedure: Diagnostic hysteroscopy and targeted endometrial biopsyWomen who did not undergo any hormonal therapy after surgery for breast cancer. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Breast cancer women with or without hormonal therapy, undergoing diagnostic hysteroscopy and targeted endometrial biopsy.
Key inclusion criteria (1 listed)
- History of breast cancer treated with surgery (regardless of the adjuvant radio/chemotherapy)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic hysteroscopy and targeted endometrial biopsyDiagnostic hysteroscopy and targeted endometrial biopsy | Procedure or surgery | Aromatase inhibitors, No treatment, Tamoxifen users |
Primary outcome
Endometrial pathologies
Time frame: 5 years after breast cancer surgery
Rate of endometrial pathologies (benign or malignant)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Derived from this study: PubMed 31425735Chiofalo 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benito Chiofalo, M.D. principal investigator
"Regina Elena" National Cancer Institute of Rome
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Endometrial Cancer, run by Università degli Studi dell'Insubria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometrial pathologies (time frame: 5 years after breast cancer surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03898947, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.