Metastatic Breast CancerReProLineNCT02393287
Retroprospective Real Life Observatory of Eribulin
An observational study of Metastatic Breast Cancer, run by Institut Cancerologie de l'Ouest at 13 sites in France.
Trial summary
The objective of this observatory is to evaluate the effecacy of Eribulin in patients with metastatic breast cancer on a recent prescription period. Part of the data collection will be retrospective and the other part will be prospective for patients started treatment by Eribulin between November 2014 and September… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Eribulin (ReProLine)
- How many people
- 753 participants
- Where
- 13 sitesFrance
- Study dates
- Nov 2014to Jan 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: The population includes all patients treated by Eribulin for breast cancer whose treatment has been starting between January 2014 and September 2015
Who may be able to join
- Age ≥ 18 years
- Patient with breast cancer, histologically proven, metastatic or locally advanced
- Patient treated by Eribulin between January and October 2014 (for the retrospective part) or between November 2014 and September 2015 (for the prospective part).
- Patient with at least an assessment of the response to Eribulin
Who cannot join
- Presence of other neoplasia
- Man
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
Institut de Cancerologie de l'Ouest
Angers, 49933
CHU Jean Minjoz
Besançon, 25030
CHU
Brest, 29200
Centre Jean Bernard
Le Mans, 72000
Centre Léon Berard
Lyon, 69373
Institut de Cancerologie de l'Ouest
Nantes, 44802
Centre Jean Godinot
Reims, 51100
Centre Eugène Marquis
Rennes, 35042
Centre Henri Becquerel
Rouen, 76038
Clinique Armoricaine de Radiologie
Saint-Brieuc, 22000
CH
St-Malo, 35400
Centre Paul Strauss
Strasbourg, 67065
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54500
About this study
Official title: Activity and Toxicity Profile of Eribulin Mesylate in Pretreated Metastatic Breast Cancer: an Observational Multicentric Retroprospective Study
The objective of this observatory is to evaluate the effecacy of Eribulin in patients with metastatic breast cancer on a recent prescription period.
Part of the data collection will be retrospective and the other part will be prospective for patients started treatment by Eribulin between November 2014 and September 2015. It will allow a better assessment on the safety profile of this drug.
Read the detailed description
Approximately one third of patients treated for localized breast cancer will present a metastatic evolution and 5% of patients are metastatic immediately.
At this stage, the malignancy is incurable with a median survival from 2 to 3 years.
Metastatic breast cancer treatment is part of a multidisciplinary approach. These two objectives are to prolong survival and improve quality of life. At present, there is no standard after the first line of chemotherapy, with fe strategy studies Eribulin is now a new therapeutic option to consider. Many patients have benefited from this treatment option and it seems interesting to evaluate in real life the effecacy and tolerance of chemotherapy.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Eribulin (ReProLine)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eribulin (ReProLine)Other
this is an observational trial ; there is no intervention
| Study group | Role | What they receive |
|---|---|---|
| Reproline | this is an observational trial ; there is no intervention Receives: Other: Eribulin (ReProLine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival is defined as the time between the first administration of Eribulin and death from any cause.
Measured: 1 year
Secondary outcomes (4)
Overall Survival by subgroup
Overall survival is defined as the time between the first administration of Eribulin and death from any cause in the following subgroups:
- According to the administration line of Eribulin: administration in third line or more versus administration in first or second line or for locally advanced cancer,
- in HER2 + population
- in triple negative population
- in the elderly (> 70 years)
- in the overweight population (BMI> 30)
Measured: 1 year
Progression free survival
Progression-free survival is defined as the time between the first administration of Eribulin and the first demonstrated progression by image
Measured: 1 year
Treatment response rate
Treatment response rate will be assessed by:
- the best response obtained between the first administration of treatment with Eribulin and demonstrated progression by image (according to RECIST 1.1 criteria) or clinical
- the clinical benefit (number of complete responses, partial responses or persistent stabilities mare than 6 months).
Measured: 1 year
Treatment's tolerance
The treatment's tolerance will be assessed by collecting adverse events ≥ grade 3 quoted according to NCI CTCAE v4.0 classification.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startNov 2014
- Primary completionSep 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Other
- Enrolment
- 753 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne PATSOURIS, MD, Principal investigator, Institut de Cancerologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393287
- Sponsor's protocol ID
- ICO-A-RSD-2014-07
- Acronym
- ReProLine
- Status last verified
- May 2019
- First submitted
- 4 Feb 2015
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activity and Toxicity Profile of Eribulin Mesylate in Pretreated Metastatic Breast Cancer: an Observational Multicentric Retroprospective Study
- ClinicalTrials.gov ID
- NCT02393287
- Acronym / sponsor ID
- ReProLine / ICO-A-RSD-2014-07
- Conditions
- Metastatic Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 753 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 19 Mar 2015 (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.
The objective of this observatory is to evaluate the effecacy of Eribulin in patients with metastatic breast cancer on a recent prescription period.
Part of the data collection will be retrospective and the other part will be prospective for patients started treatment by Eribulin between November 2014 and September 2015. It will allow a better assessment on the safety profile of this drug.
Detailed description
Approximately one third of patients treated for localized breast cancer will present a metastatic evolution and 5% of patients are metastatic immediately.
At this stage, the malignancy is incurable with a median survival from 2 to 3 years.
Metastatic breast cancer treatment is part of a multidisciplinary approach. These two objectives are to prolong survival and improve quality of life. At present, there is no standard after the first line of chemotherapy, with fe strategy studies Eribulin is now a new therapeutic option to consider. Many patients have benefited from this treatment option and it seems interesting to evaluate in real life the effecacy and tolerance of chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reproline | – | Other: Eribulin (ReProLine)this is an observational trial ; there is no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population includes all patients treated by Eribulin for breast cancer whose treatment has been starting between January 2014 and September 2015
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Patient with breast cancer, histologically proven, metastatic or locally advanced
- Patient treated by Eribulin between January and October 2014 (for the retrospective part) or between November 2014 and September 2015 (for the prospective part).
- Patient with at least an assessment of the response to Eribulin
Key exclusion criteria (2 listed)
- Presence of other neoplasia
- Man
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 |
|---|---|---|
| Eribulin (ReProLine)this is an observational trial ; there is no intervention | Other | Reproline |
Primary outcome
Overall Survival
Time frame: 1 year
Overall survival is defined as the time between the first administration of Eribulin and death from any cause.
4 secondary outcomes
Overall Survival by subgroup
Time frame: 1 year
Progression free survival
Time frame: 1 year
Treatment response rate
Time frame: 1 year
Treatment's tolerance
Time frame: 1 year
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 9 May 2019.
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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.
Anne PATSOURIS, MD principal investigator
Institut de Cancerologie de l'Ouest
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by Institut Cancerologie de l'Ouest at 13 sites 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 4 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: finished, as of the sponsor's last update on 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
Overall Survival (time frame: 1 year). 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 9 May 2019.