Breast CancerHACAMINCT02791750
5 Years Follow-up With Adjuvant Therapy for Women With Breast Invasive Carcinoma
An observational study of Breast Cancer, run by Institut de Cancérologie de Lorraine at 1 site in France.
Trial summary
Non-persistence to adjuvant hormonal therapy for breast cancer at 5 years decrease its efficacy. The objective of this study is to know the women experience (persistence, treatment changes, quality of life) and its determinants, in a french population. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- questionnary of quality of life
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2016to 3 Jun 2017
- 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 following-up in the Lorraine Institute of Oncology at 5 years of the beginning of an adjuvant hormonal therapy
Who may be able to join
- Patients following-up in the Lorraine Institute of Oncology at 5 years of the beginning of an adjuvant hormonal therapy
- Women with breast invasive carcinoma positive-RH and indication of adjuvant hormonal therapy
- Adult patients
- Being capable and agree to follow the study procedure
- Patients informed and non-opposed
- Covered by social security
Who cannot join
- History of other cancer except basal cell carcinoma
- Patients with breast invasive carcinoma negative-RH
- Synchronous metastases
- Relapsed
- Previous adjuvant hormonal therapy
- Men
- Patients with guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 5 Years Follow-up in the Lorraine Institute of Oncology With Adjuvant Therapy for Women With Breast Invasive Carcinoma
Non-persistence to adjuvant hormonal therapy for breast cancer at 5 years decrease its efficacy. The objective of this study is to know the women experience (persistence, treatment changes, quality of life) and its determinants, in a french population.
- Conditions
- Breast Cancer
- Being tested
- questionnary of quality of life
- Keywords
- hormone replacement therapy, breast cancer, follow up
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnary of quality of lifeOther
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients followed for a medical consultation in the Institut de Cancérologie de Lorraine at 5 years of the beginning of an adjuvant hormonal therapy. Receives: Other: questionnary of quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors associated with persistence to hormone therapy for breast cancer
Women will be classed as persistent if they don't discontinue or abandon hormone therapy during the 5 years after the introduction of the medication. The information will be recorded thanks to a self-questionnary fulfilled the inclusion day.
The baseline characteristics will be compared between persistent women and non-persistent women.
Measured: 1 day
Secondary outcomes (4)
Comparison of the quality of life
Quality of life between patients who continued hormone therapy for 5 years and patients who discontinued treatment early will be searched for using the questionnaire
Measured: 1 day
Proportion of women with a change in their treatment
Proportion of women who have changed treatment within 5 years following the placing on hormone therapy and reasons for the change.
Measured: 1 day
Cause of treatment discontinuation
In the subgroup of women who stopped hormone therapy within 5 years following the hormone therapy, determination of the treatment discontinuation.
Measured: 1 day
Continued homonotherapy
In the subgroup of women who have been treated with hormone therapy for 5 years, determine the proportion of women not opposed to the continuation of hormone therapy beyond 5 years
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study start3 Jun 2016
- Primary completion3 Jun 2017
- Study completion3 Jun 2017
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.
- 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LESUR ANNE, Md, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791750
- Sponsor's protocol ID
- ICL OBS 02
- Acronym
- HACAMI
- Status last verified
- Aug 2018
- First submitted
- 25 May 2016
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5 Years Follow-up in the Lorraine Institute of Oncology With Adjuvant Therapy for Women With Breast Invasive Carcinoma
- ClinicalTrials.gov ID
- NCT02791750
- Acronym / sponsor ID
- HACAMI / ICL OBS 02
- Conditions
- Breast Cancer
- Keywords
- hormone replacement therapy, breast cancer, follow up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 3 Jun 2016 (actual)
- Primary completion
- 3 Jun 2017 (actual)
- Study completion
- 3 Jun 2017 (actual)
- First posted
- 7 Jun 2016 (estimated)
- 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.
Non-persistence to adjuvant hormonal therapy for breast cancer at 5 years decrease its efficacy. The objective of this study is to know the women experience (persistence, treatment changes, quality of life) and its determinants, in a french population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: questionnary of quality of lifePatients followed for a medical consultation in the Institut de Cancérologie de Lorraine at 5 years of the beginning of an adjuvant hormonal therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients following-up in the Lorraine Institute of Oncology at 5 years of the beginning of an adjuvant hormonal therapy
Key inclusion criteria (6 listed)
- Patients following-up in the Lorraine Institute of Oncology at 5 years of the beginning of an adjuvant hormonal therapy
- Women with breast invasive carcinoma positive-RH and indication of adjuvant hormonal therapy
- Adult patients
- Being capable and agree to follow the study procedure
- Patients informed and non-opposed
Key exclusion criteria (7 listed)
- History of other cancer except basal cell carcinoma
- Patients with breast invasive carcinoma negative-RH
- Synchronous metastases
- Relapsed
- Previous adjuvant 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 |
|---|---|---|
| questionnary of quality of life | Other | Observational |
Primary outcome
Factors associated with persistence to hormone therapy for breast cancer
Time frame: 1 day
Women will be classed as persistent if they don't discontinue or abandon hormone therapy during the 5 years after the introduction of the medication. The information will be recorded thanks to a self-questionnary fulfilled the inclusion day. The baseline characteristics will be compared between persistent women and non-persistent women.
4 secondary outcomes
Comparison of the quality of life
Time frame: 1 day
Proportion of women with a change in their treatment
Time frame: 1 day
Cause of treatment discontinuation
Time frame: 1 day
Continued homonotherapy
Time frame: 1 day
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 8 Aug 2018.
- Individual participant dataSharing planned: No
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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.
LESUR ANNE, Md principal investigator
Institut de Cancérologie de Lorraine
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, run by Institut de Cancérologie de Lorraine at 1 site in France.
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 6 inclusion and 7 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 8 Aug 2018. 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 France. 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?
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?
Factors associated with persistence to hormone therapy for breast cancer (time frame: 1 day). 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 8 Aug 2018.