Breast Cancer PatientsLorelineNCT03771183
Loreline Study: Characterization of Long Responders Under Eribuline
An observational study of Breast Cancer Patients and Therapy Related Tumor, run by Centre Jean Perrin at 5 sites in France.
Trial summary
There is currently no strict recommendations for the management of patients who have received at least one or two lines of anthracyclines-based chemotherapy and taxane therapy for advanced breast cancer. However, Halaven® can represent a therapeutic alternative at this stage of the disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer Patients, Therapy Related Tumor
- What is being tested?
- Patients in long response during Halaven® treatment
- How many people
- 97 participants
- Where
- 5 sitesFrance
- Study dates
- 23 Aug 2019to 28 Feb 2021
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This is a nationale, multicentric, retrospective study in which will be inclused metastatic breast cancer patients treated by Halaven® in second, third line or fourth line. Only "long responder" patients treated by Halaven®, since Septembre 2011 to December 2016, will be included in this study. A patient will be considered as " long responder " if she is in objective response or stability for 6 months or more from the start of Halaven® treatment
Who may be able to join
- Women aged between 18 and 75 years
- Metastatic breast cancer patient
- Patients treated by Halaven® in second, third or fourth line of treatment for their metastatic breast cancer
- Halaven® treatment must have been received between September 2011 and December 2016
- Patients responding or in stability during at least 6 months under Halaven® treatment
- Patients pretreated by at least one line of any other chemotherapy
- Non opposition form dated and signed by the investigator (attesting that the patient consented orally that clinical, biological and imaging data concerning her were analyzed in this study)
Who cannot join
- Male
- Patient with cognitive and psychiatric disorders
- Patient deprived of liberty by judicial or administrative decision
- Insufficient knowledge or understanding of the French language which does not allow for the non-opposition form to be understood
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHRU Jean Minoz
Besançon, 25030
Centre Jean Perrin
Clermont-Ferrand, 63011
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42270
Centre Paul Strauss
Strasbourg, 67065
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519
About this study
Official title: National Retrospective Study to Characterize LOng REsponder Under EribuLINE (HALAVEN®) Metastatic Breast Cancer Patients
There is currently no strict recommendations for the management of patients who have received at least one or two lines of anthracyclines-based chemotherapy and taxane therapy for advanced breast cancer. However, Halaven® can represent a therapeutic alternative at this stage of the disease.
Indeed, since march 2011, Halaven® has been granted Marketing Authorization (MA) for patients with metastatic or locally advanced breast cancer, whose disease has progressed after at least two lines of chemotherapy for advanced disease (3rd line). In these patients, the indication for marketing authorization specifies that the previous treatment must have included an anthracycline and a taxane except in patients who can not receive these treatments.
Read more
An extension of indication was obtained on 27/06/2014 with a marketing authorization obtained in the treatment of locally advanced or second-line metastatic breast cancer.
According to the Transparency Commission of the High Authority of Health (HAS dated September 23, 2015), Halaven® (Eribulin), administered as monotherapy, in the third line of treatment and beyond, represents a therapeutic option, because it brings an improvement of medical service rendered compared to Capecitabine (XELODA®) and Vinorelbine (NAVELBINE®).
In addition, Halaven® (Eribuline) administrated as monotherapy in second-line of treatment is an alternative to other monotherapies recommended for the treatment of locally advanced or metastatic relapsed breast cancer, such as Capecitabine (XELODA®). and Vinorelbine (NAVELBINE®). But, no improvement of medical service rendered has been reported in second line of treatment.
According to these results, it would be interesting to have additional data concerning the use of Halaven® (Eribulin), in the second and third lines, but also in the fourth line.
For this purpose, the investigators propose to perform a study in patients with metastatic breast cancer who have failed treatment after the first line and beyond.
In this study, the investigators will be particularly interested in "long-responder" patients, that is to say, in objective response or with stability for 6 months or more under Halaven®, in order to better characterize these patients. Patients must have been treated by Halaven between September 2011 and December 2016, to have a sufficient follow-up for the survival data of the patients.
Read the detailed description
The investigators will perform a cross-sectional study in patients with metastatic breast cancer who have failed treatment after the first line and beyond.
In this study, the investigators will be particularly interested in "long-responder" patients, that is to say, in objective response or with stability for 6 months or more under Halaven®, in order to better characterize these patients. Patients must have been treated by Halaven between September 2011 (the year of obtaining the MA in the 3rd line of treatment) and December 2016, to have a sufficient follow-up for the survival data of the patients.
The investigators will also focus on patients with liver metastases because there is limited data in this population.
- Conditions
- Breast Cancer Patients, Therapy Related Tumor
- Being tested
- Patients in long response during Halaven® treatment
- Medical subject headings
- Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients in long response during Halaven® treatmentOther
Data collection
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure patient's age at the beginning of Halaven® treatment in patients who received Halaven® and who were in response since 6 months or more
-patient's age at the beginning of Halaven® treatment
Measured: up to at least 6 months after Halaven® start
Characterize tumor of patients who received Halaven® and who were in response since 6 months or more
histological tumoral type
Measured: up to at least 6 months after Halaven® start
Characterize patients who received Halaven® and who were in response since 6 months or more, according to previous treatments (neoadjuvant and/or adjuvant treatments)
number of patients who have received neoadjuvant treatments number of patients who have received adjuvant treatments
Measured: up to at least 6 months after Halaven® start
Characterize patients who received Halaven® and who were in response since 6 months or more, according to the number of lines of treatment received for metastatic disease
-number of lines of treatment received for metastatic disease, including treatment received before Halaven®
Measured: up to at least 6 months after Halaven® start
Characterize metastatic localizations of patients who received Halaven® and who were in response since 6 months or more
number of patients with metastatic localizations
Measured: up to at least 6 months after Halaven® start
Characterize patients who received Halaven® and who were in response since 6 months or more
number of patients with liver metastasis, surgery of liver metastasis
Measured: up to at least 6 months after Halaven® start
Measure the number of Halaven® injections to obtaine the "best" response in patients who received Halaven® and who were in response since 6 months or more
-number of Halaven® injections until the " best " response is obtained
Measured: up to at least 6 months after Halaven® start
Measure the best response under Halaven® in patients who received Halaven® and who were in response since 6 months or more
-duration of the " best " response under Halaven® (in months)
Measured: up to at least 6 months after Halaven® start
Measure hormonal receptors tumours of patients who received Halaven® and who were in response since 6 months or more
hormonal receptors of primitive tumor (percentage of stained cells)
Measured: up to at least 6 months after Halaven® start
Measure KI-67 tumours of patients who received Halaven® and who were in response since 6 months or more
-pathology of primitive cancer : ki-67
Measured: up to at least 6 months after Halaven® start
Measure Scarff Bloom Richardson grade tumours of patients who received Halaven® and who were in response since 6 months or more
-pathology of primitive cancer : Scarff Bloom Richardson grade The Scarff Bloom Richardson garde will be measured with a scale from I to III. A grade III represent a worse outcome.
Measured: up to at least 6 months after Halaven® start
Secondary outcomes (7)
Measure Percentage of long responders patients under Halaven® among patients treated by Halaven® in second, third and fourth line of treatment
Percentage of patients in objective response or in stability during 6 months and more since the beginning of Halaven® treatment among all patients treated by Halaven® (in second, third and fourth line of treatment). This percentage will be collected in each participating center at the end of the study.
Measured: up to at least 6 months after Halaven® start
-Evaluate the percentage of patients with hepatic metastases
-Percentage of liver metastatic patients
Measured: up to at least 6 months after Halaven® start
-Evaluate the specific response and/or stability in patients with hepatic metastases, that is measure percentage of liver metastatic patients in complete or partial response or in stability under Halaven®
-Percentage of liver metastatic patients in complete or partial response or in stability under Halaven®
Measured: up to at least 6 months after Halaven® start
-Evaluate toxicities due to the use of Halaven®
Number and percentage of patients who have a grade 3 and a grade 4 toxicity (for each toxicity reported)
-Collection of toxicities under Halaven® Toxicities considered are toxicities grade 3, 4 and 5 (CTCAE V4.03 dated on june 14, 2010) : nausea, vomiting,diarrhea, neutropenia, anemia, leucopenia, fatigue, peripheral neuropathy, alopecia, loss of apetite. If others toxicities appear, they will be notified in the e-CRF.
Measured: up to at least 6 months after Halaven® start
-Evaluation of percentage of patients in complete or partial response or in stability under Halaven® according to number of previous metastatic treatment lines
-Percentage of patients in complete or partial reponse or in stability under Halaven®. This percentage will be calculated in patients treated by Halaven® in second, third or fourth line of treatment
Measured: up to at least 6 months after Halaven® start
-Evaluation of Progression Free Survival (PFS)
-Measure of time to progression (in months or in years) The PFS will be calculated from date of Halaven start to first progression date whatever the type of progression (local progression, progression of a previous metastasis and/or appearance of new metastasis, and/or new cancer).
Measured: up to at least 6 months after Halaven® start
Evaluation of overall survival
Measure of overall survival (in months or in years) Overall survival calculated from start of Halaven to death, whatever the cause, or date of last consultation if patients are alive at the 12/31/2017.
Measured: up to at least 6 months after Halaven® start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start23 Aug 2019
- Primary completion30 Nov 2020
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer PatientsStudies 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
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Ange MOURET-REYNIER, MD, Principal investigator, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771183
- Sponsor's protocol ID
- 2018-A03054-51
- Acronym
- Loreline
- Status last verified
- Apr 2021
- First submitted
- 28 Nov 2018
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Retrospective Study to Characterize LOng REsponder Under EribuLINE (HALAVEN®) Metastatic Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03771183
- Acronym / sponsor ID
- Loreline / 2018-A03054-51
- Conditions
- Breast Cancer Patients, Therapy Related Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 11 Dec 2018 (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.
There is currently no strict recommendations for the management of patients who have received at least one or two lines of anthracyclines-based chemotherapy and taxane therapy for advanced breast cancer. However, Halaven® can represent a therapeutic alternative at this stage of the disease.
Indeed, since march 2011, Halaven® has been granted Marketing Authorization (MA) for patients with metastatic or locally advanced breast cancer, whose disease has progressed after at least two lines of chemotherapy for advanced disease (3rd line). In these patients, the indication for marketing authorization specifies that the previous treatment must have included an anthracycline and a taxane except in patients who can not receive these treatments.
An extension of indication was obtained on 27/06/2014 with a marketing authorization obtained in the treatment of locally advanced or second-line metastatic breast cancer.
According to the Transparency Commission of the High Authority of Health (HAS dated September 23, 2015), Halaven® (Eribulin), administered as monotherapy, in the third line of treatment and beyond, represents a therapeutic option, because it brings an improvement of medical service rendered compared to Capecitabine (XELODA®) and Vinorelbine (NAVELBINE®).
In addition, Halaven® (Eribuline) administrated as monotherapy in second-line of treatment is an alternative to other monotherapies recommended for the treatment of locally advanced or metastatic relapsed breast cancer, such as Capecitabine (XELODA®). and Vinorelbine (NAVELBINE®). But, no improvement of medical service rendered has been reported in second line of treatment.
According to these results, it would be interesting to have additional data concerning the use of Halaven® (Eribulin), in the second and third lines, but also in the fourth line.
For this purpose, the investigators propose to perform a study in patients with metastatic breast cancer who have failed treatment after the first line and beyond.
In this study, the investigators will be particularly interested in "long-responder" patients, that is to say, in objective response or with stability for 6 months or more under Halaven®, in order to better characterize these patients. Patients must have been treated by Halaven between September 2011 and December 2016, to have a sufficient follow-up for the survival data of the patients.
Detailed description
The investigators will perform a cross-sectional study in patients with metastatic breast cancer who have failed treatment after the first line and beyond.
In this study, the investigators will be particularly interested in "long-responder" patients, that is to say, in objective response or with stability for 6 months or more under Halaven®, in order to better characterize these patients. Patients must have been treated by Halaven between September 2011 (the year of obtaining the MA in the 3rd line of treatment) and December 2016, to have a sufficient follow-up for the survival data of the patients.
The investigators will also focus on patients with liver metastases because there is limited data in this population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a nationale, multicentric, retrospective study in which will be inclused metastatic breast cancer patients treated by Halaven® in second, third line or fourth line. Only "long responder" patients treated by Halaven®, since Septembre 2011 to December 2016, will be included in this study. A patient will be considered as " long responder " if she is in objective response or stability for 6 months or more from the start of Halaven® treatment
Key inclusion criteria (7 listed)
- Women aged between 18 and 75 years
- Metastatic breast cancer patient
- Patients treated by Halaven® in second, third or fourth line of treatment for their metastatic breast cancer
- Halaven® treatment must have been received between September 2011 and December 2016
- Patients responding or in stability during at least 6 months under Halaven® treatment
Key exclusion criteria (4 listed)
- Male
- Patient with cognitive and psychiatric disorders
- Patient deprived of liberty by judicial or administrative decision
- Insufficient knowledge or understanding of the French language which does not allow for the non-opposition form to be understood
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 |
|---|---|---|
| Patients in long response during Halaven® treatmentData collection | Other | – |
Primary outcome
Measure patient's age at the beginning of Halaven® treatment in patients who received Halaven® and who were in response since 6 months or more
Time frame: up to at least 6 months after Halaven® start
-patient's age at the beginning of Halaven® treatment
Characterize tumor of patients who received Halaven® and who were in response since 6 months or more
Time frame: up to at least 6 months after Halaven® start
histological tumoral type
Characterize patients who received Halaven® and who were in response since 6 months or more, according to previous treatments (neoadjuvant and/or adjuvant treatments)
Time frame: up to at least 6 months after Halaven® start
number of patients who have received neoadjuvant treatments number of patients who have received adjuvant treatments
Characterize patients who received Halaven® and who were in response since 6 months or more, according to the number of lines of treatment received for metastatic disease
Time frame: up to at least 6 months after Halaven® start
-number of lines of treatment received for metastatic disease, including treatment received before Halaven®
Characterize metastatic localizations of patients who received Halaven® and who were in response since 6 months or more
Time frame: up to at least 6 months after Halaven® start
number of patients with metastatic localizations
Characterize patients who received Halaven® and who were in response since 6 months or more
Time frame: up to at least 6 months after Halaven® start
number of patients with liver metastasis, surgery of liver metastasis
Measure the number of Halaven® injections to obtaine the "best" response in patients who received Halaven® and who were in response since 6 months or more
Time frame: up to at least 6 months after Halaven® start
-number of Halaven® injections until the " best " response is obtained
Measure the best response under Halaven® in patients who received Halaven® and who were in response since 6 months or more
Time frame: up to at least 6 months after Halaven® start
-duration of the " best " response under Halaven® (in months)
Measure hormonal receptors tumours of patients who received Halaven® and who were in response since 6 months or more
Time frame: up to at least 6 months after Halaven® start
hormonal receptors of primitive tumor (percentage of stained cells)
Measure KI-67 tumours of patients who received Halaven® and who were in response since 6 months or more
Time frame: up to at least 6 months after Halaven® start
-pathology of primitive cancer : ki-67
Measure Scarff Bloom Richardson grade tumours of patients who received Halaven® and who were in response since 6 months or more
Time frame: up to at least 6 months after Halaven® start
-pathology of primitive cancer : Scarff Bloom Richardson grade The Scarff Bloom Richardson garde will be measured with a scale from I to III. A grade III represent a worse outcome.
7 secondary outcomes
Measure Percentage of long responders patients under Halaven® among patients treated by Halaven® in second, third and fourth line of treatment
Time frame: up to at least 6 months after Halaven® start
-Evaluate the percentage of patients with hepatic metastases
Time frame: up to at least 6 months after Halaven® start
-Evaluate the specific response and/or stability in patients with hepatic metastases, that is measure percentage of liver metastatic patients in complete or partial response or in stability under Halaven®
Time frame: up to at least 6 months after Halaven® start
-Evaluate toxicities due to the use of Halaven®
Time frame: up to at least 6 months after Halaven® start
-Evaluation of percentage of patients in complete or partial response or in stability under Halaven® according to number of previous metastatic treatment lines
Time frame: up to at least 6 months after Halaven® start
-Evaluation of Progression Free Survival (PFS)
Time frame: up to at least 6 months after Halaven® start
Evaluation of overall survival
Time frame: up to at least 6 months after Halaven® start
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 5 Apr 2021.
- 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.
Marie-Ange MOURET-REYNIER, MD principal investigator
Centre Jean Perrin
5 sites 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 Patients and Therapy Related Tumor, run by Centre Jean Perrin at 5 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 7 inclusion and 4 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 5 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Measure patient's age at the beginning of Halaven® treatment in patients who received Halaven® and who were in response since 6 months or more (time frame: up to at least 6 months after Halaven® start). The study lists 11 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 5 Apr 2021.