Clinical trial NCT03771183: Loreline Study: Characterization of Long Responders Under Eribuline
Official title: National Retrospective Study to Characterize LOng REsponder Under EribuLINE (HALAVEN®) Metastatic Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Patients
Therapy Related Tumor
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 97
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
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
timeFrame: up to at least 6 months after Halaven® start
measure: Characterize tumor of patients who received Halaven® and who were in response since 6 months or more
timeFrame: up to at least 6 months after Halaven® start
measure: Characterize patients who received Halaven® and who were in response since 6 months or more, according to previous treatments (neoadjuvant and/or adjuvant treatments)
timeFrame: up to at least 6 months after Halaven® start
measure: 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
timeFrame: up to at least 6 months after Halaven® start
measure: Characterize metastatic localizations of patients who received Halaven® and who were in response since 6 months or more
timeFrame: up to at least 6 months after Halaven® start
measure: Characterize patients who received Halaven® and who were in response since 6 months or more
timeFrame: up to at least 6 months after Halaven® start
measure: 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
timeFrame: up to at least 6 months after Halaven® start
measure: Measure the best response under Halaven® in patients who received Halaven® and who were in response since 6 months or more
timeFrame: up to at least 6 months after Halaven® start
measure: Measure hormonal receptors tumours of patients who received Halaven® and who were in response since 6 months or more
timeFrame: up to at least 6 months after Halaven® start
measure: Measure KI-67 tumours of patients who received Halaven® and who were in response since 6 months or more
timeFrame: up to at least 6 months after Halaven® start
measure: Measure Scarff Bloom Richardson grade tumours of patients who received Halaven® and who were in response since 6 months or more
timeFrame: up to at least 6 months after Halaven® start
Secondary outcomes:
measure: Measure Percentage of long responders patients under Halaven® among patients treated by Halaven® in second, third and fourth line of treatment
timeFrame: up to at least 6 months after Halaven® start
measure: -Evaluate the percentage of patients with hepatic metastases
timeFrame: up to at least 6 months after Halaven® start
measure: -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®
timeFrame: up to at least 6 months after Halaven® start
measure: -Evaluate toxicities due to the use of Halaven®
timeFrame: up to at least 6 months after Halaven® start
measure: -Evaluation of percentage of patients in complete or partial response or in stability under Halaven® according to number of previous metastatic treatment lines
timeFrame: up to at least 6 months after Halaven® start
measure: -Evaluation of Progression Free Survival (PFS)
timeFrame: up to at least 6 months after Halaven® start
measure: Evaluation of overall survival
timeFrame: up to at least 6 months after Halaven® start
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHRU Jean Minoz
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Saint Priest en Jarez
country: France
facility: Institut de Cancérologie Lucien Neuwirth
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: Centre Jean Perrin
name: Marie-Ange MOURET-REYNIER, MD
role: PRINCIPAL_INVESTIGATOR
References: