Loreline Study: Characterization of Long Responders Under Eribuline (Loreline)

April 2, 2021 updated by: Centre Jean Perrin

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.

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.

Study Overview

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 Type

Observational

Enrollment (Actual)

97

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Besançon, France, 25030
        • CHRU Jean Minoz
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin
      • Saint Priest en Jarez, France, 42270
        • Institut de Cancerologie Lucien Neuwirth
      • Strasbourg, France, 67065
        • Centre PAUL STRAUSS
      • Vandœuvre-lès-Nancy, France, 54519
        • Institut de Cancérologie de Lorraine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: up to at least 6 months after Halaven® start
histological tumoral type
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)
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
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
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®
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
Time Frame: up to at least 6 months after Halaven® start
number of patients with metastatic localizations
up to at least 6 months after Halaven® start
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
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
Time Frame: up to at least 6 months after Halaven® start
-number of Halaven® injections until the " best " response is obtained
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
Time Frame: up to at least 6 months after Halaven® start
-duration of the " best " response under Halaven® (in months)
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
Time Frame: up to at least 6 months after Halaven® start
hormonal receptors of primitive tumor (percentage of stained cells)
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
Time Frame: up to at least 6 months after Halaven® start
-pathology of primitive cancer : ki-67
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
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.
up to at least 6 months after Halaven® start

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
-Percentage of liver metastatic patients
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
-Percentage of liver metastatic patients in complete or partial response or in stability under Halaven®
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

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.

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
-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
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
-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).
up to at least 6 months after Halaven® start
Evaluation of overall survival
Time Frame: up to at least 6 months after Halaven® start
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.
up to at least 6 months after Halaven® start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 23, 2019

Primary Completion (ACTUAL)

November 30, 2020

Study Completion (ACTUAL)

February 28, 2021

Study Registration Dates

First Submitted

November 28, 2018

First Submitted That Met QC Criteria

December 7, 2018

First Posted (ACTUAL)

December 11, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 5, 2021

Last Update Submitted That Met QC Criteria

April 2, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2018-A03054-51

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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