Breast CancerELENANCT03939156
Patients' Preferences for Adjuvant Endocrine Therapy in Early Breast Cancer
An observational study of Breast Cancer and Endocrine Breast Diseases, run by European Institute of Oncology at 1 site in Italy.
Trial summary
Preference studies reveal how individuals trade-off the potential benefits, harms and inconveniences of a treatment by determining the minimum benefits they judge sufficient to make the treatment worthwhile. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Endocrine Breast Diseases
- What is being tested?
- Completion of questionnaires
- How many people
- 450 participants
- Where
- 1 siteItaly
- Study dates
- 5 Jun 2018to 31 Dec 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hormonal receptors positive breast cancer candidate to adjuvant hormonal therapy or who are receiving hormonal therapy (within 1 year from beginning for group 2 and who are received at least 4 or 5 or 6 years of hormonal therapy)
Who may be able to join
- Women candidate to adjuvant hormonal therapy for breast cancer before the start of therapy
- Women who are receiving hormonal therapy (within 1 year from beginning)
- Women who are receiving hormonal therapy (who had receive at least 4 or 5 or 6 years of hormonal therapy)
- Patients who underwent to radical surgery for breast cancer
- Patients who have received neoadjuvant or adjuvant chemotherapy are also eligible
- Hormonal receptors positive breast cancer (ER and or PgR >1%)
- Sufficient literacy in Italian to complete the questionnaires.
Who cannot join
- Patients who had received at least 1 year and no more than 3 years of hormonal therapy
- Patients who are receiving hormonal therapy (who had receive 7 years or more of hormonal therapy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Endocrine Therapy and Patients Preferences in Early Breast Cancer - Patients' Preferences for Adjuvant Endocrine Therapy in Early Breast Cancer.
Preference studies reveal how individuals trade-off the potential benefits, harms and inconveniences of a treatment by determining the minimum benefits they judge sufficient to make the treatment worthwhile.
They are especially relevant to adjuvant therapies where individuals must weigh up modest survival benefits only realized in time by no recurrence of their cancer with side effects predominantly experienced whilst on the treatment.
Read more
Previously it was reported, for example, that over 50% of women who had adjuvant chemotherapy for early breast cancer judged a 1% improvement in 5 year survival rates sufficient to make it worthwhile.
Larger survival benefits were required for longer duration adjuvant hormonal therapy where over 50% of women required at least 5% improvement in 5 year survival rates to make it worthwhile.
Read the detailed description
The endocrine therapy is generally proposed to all patients with endocrine positive early breast cancer to reduce the risk of recurrence and death. Moreover several data support that the prolongation of hormonal therapy (i.e. 10 years of hormonal treatment) is associated with statistical improved outcome.
In order to achieve the benefit related to hormonal therapy all women have to be treated despite the fact that the data and analyses are unable to differentiate as to whether a small prolongation in survival accrues to all women treated or a few patients survive who would otherwise have died. Moreover the hormonal therapy is associated with side effects that may impact the quality of life of the patients.
Patients are more likely to accept treatment on the basis of presented relative rather than absolute risks and so the question arises as to whether unrealistic improvements in outcome are expected by patients.
The interviews with patients in the proposed trial will elicit the expected gains both in terms of survival and life years and will be able to assess the proportion of patients who considered an improvement of realistic size was sufficient to justify the treatment and the prolongation of the treatment.
Several studies showed that choices are guided by the personal attitude to react and adapt to traumatic events, individual resilience.
It is important therefore to consider also the influence of these factors on the patients' treatment preferences.
For this reason, besides the elicitation of preferences, resilience and reaction to traumatic events will be assessed thorough validated questionnaires.
- Conditions
- Breast Cancer, Endocrine Breast Diseases
- Being tested
- Completion of questionnaires
- Keywords
- adjuvant endocrine therapy, patient's preferences
- Medical subject headings
- Breast Neoplasms, Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Completion of questionnairesOther
Completion of questionnaires at the time of study entry
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - before starting ET | women candidate to receive ET and interviewed before starting treatment Receives: Other: Completion of questionnaires | |
| Group 2 - within 1 year of ET | women interviewed within 1 years from beginning of ET Receives: Other: Completion of questionnaires | |
| Group 3 - between 4 and 6 years of ET | women interviewed after more than 4 years but no more than 6 years of ET Receives: Other: Completion of questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of risk reduction needed to consider endocrine therapy worthwhile
Risk reduction will be evaluated in the 40% and 20% 5 years risk scenarios
Measured: 1 week
Number of years gain needed to consider ET worthwhile
Prolonged survival time gain will be evaluated in the 5-yr and 15-yr survival scenarios
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start5 Jun 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilia Montagna, MD, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939156
- Sponsor's protocol ID
- IEO 0837/
- Acronym
- ELENA
- Status last verified
- Jun 2023
- First submitted
- 4 Apr 2019
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Endocrine Therapy and Patients Preferences in Early Breast Cancer - Patients' Preferences for Adjuvant Endocrine Therapy in Early Breast Cancer.
- ClinicalTrials.gov ID
- NCT03939156
- Acronym / sponsor ID
- ELENA / IEO 0837/
- Conditions
- Breast Cancer, Endocrine Breast Diseases
- Keywords
- adjuvant endocrine therapy, patient's preferences
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 May 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.
Preference studies reveal how individuals trade-off the potential benefits, harms and inconveniences of a treatment by determining the minimum benefits they judge sufficient to make the treatment worthwhile.
They are especially relevant to adjuvant therapies where individuals must weigh up modest survival benefits only realized in time by no recurrence of their cancer with side effects predominantly experienced whilst on the treatment.
Previously it was reported, for example, that over 50% of women who had adjuvant chemotherapy for early breast cancer judged a 1% improvement in 5 year survival rates sufficient to make it worthwhile.
Larger survival benefits were required for longer duration adjuvant hormonal therapy where over 50% of women required at least 5% improvement in 5 year survival rates to make it worthwhile.
Detailed description
The endocrine therapy is generally proposed to all patients with endocrine positive early breast cancer to reduce the risk of recurrence and death. Moreover several data support that the prolongation of hormonal therapy (i.e. 10 years of hormonal treatment) is associated with statistical improved outcome.
In order to achieve the benefit related to hormonal therapy all women have to be treated despite the fact that the data and analyses are unable to differentiate as to whether a small prolongation in survival accrues to all women treated or a few patients survive who would otherwise have died. Moreover the hormonal therapy is associated with side effects that may impact the quality of life of the patients.
Patients are more likely to accept treatment on the basis of presented relative rather than absolute risks and so the question arises as to whether unrealistic improvements in outcome are expected by patients.
The interviews with patients in the proposed trial will elicit the expected gains both in terms of survival and life years and will be able to assess the proportion of patients who considered an improvement of realistic size was sufficient to justify the treatment and the prolongation of the treatment.
Several studies showed that choices are guided by the personal attitude to react and adapt to traumatic events, individual resilience.
It is important therefore to consider also the influence of these factors on the patients' treatment preferences.
For this reason, besides the elicitation of preferences, resilience and reaction to traumatic events will be assessed thorough validated questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 - before starting ET | – | Other: Completion of questionnaireswomen candidate to receive ET and interviewed before starting treatment |
| Group 2 - within 1 year of ET | – | Other: Completion of questionnaireswomen interviewed within 1 years from beginning of ET |
| Group 3 - between 4 and 6 years of ET | – | Other: Completion of questionnaireswomen interviewed after more than 4 years but no more than 6 years of ET |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hormonal receptors positive breast cancer candidate to adjuvant hormonal therapy or who are receiving hormonal therapy (within 1 year from beginning for group 2 and who are received at least 4 or 5 or 6 years of hormonal therapy)
Key inclusion criteria (7 listed)
- Women candidate to adjuvant hormonal therapy for breast cancer before the start of therapy
- Women who are receiving hormonal therapy (within 1 year from beginning)
- Women who are receiving hormonal therapy (who had receive at least 4 or 5 or 6 years of hormonal therapy)
- Patients who underwent to radical surgery for breast cancer
- Patients who have received neoadjuvant or adjuvant chemotherapy are also eligible
Key exclusion criteria (2 listed)
- Patients who had received at least 1 year and no more than 3 years of hormonal therapy
- Patients who are receiving hormonal therapy (who had receive 7 years or more of hormonal therapy)
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 |
|---|---|---|
| Completion of questionnairesCompletion of questionnaires at the time of study entry | Other | Group 1 - before starting ET, Group 2 - within 1 year of ET, Group 3 - between 4 and 6 years of ET |
Primary outcome
Percentage of risk reduction needed to consider endocrine therapy worthwhile
Time frame: 1 week
Risk reduction will be evaluated in the 40% and 20% 5 years risk scenarios
Number of years gain needed to consider ET worthwhile
Time frame: 1 week
Prolonged survival time gain will be evaluated in the 5-yr and 15-yr survival scenarios
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- 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.
Emilia Montagna, MD principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Endocrine Breast Diseases, run by European Institute of Oncology at 1 site in Italy.
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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Percentage of risk reduction needed to consider endocrine therapy worthwhile (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2023.