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NCT Number: NCT03771183

Loreline Study: Characterization of Long Responders Under Eribuline

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.

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Key information

Conditions

Breast Cancer Patients Neoplasms Neoplasms, Second Primary Therapy Related Tumor

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

CHRU Jean Minoz, Besançon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patients in long response during Halaven® treatment

Other

Data collection

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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®

  5. 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

  6. 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

  7. 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

  8. 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)

  9. 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)

  10. 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

  11. 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.

Secondary outcomes

  1. 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.

  2. -Evaluate the percentage of patients with hepatic metastases

    Time frame: up to at least 6 months after Halaven® start

    -Percentage of liver metastatic patients

  3. -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®

  4. -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.

  5. -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

  6. -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).

  7. 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.

Sponsors and collaborators

Lead sponsor

Centre Jean Perrin

Other

Registry information

Official study title

National Retrospective Study to Characterize LOng REsponder Under EribuLINE (HALAVEN®) Metastatic Breast Cancer Patients

Acronym: Loreline

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Dec 11, 2018
Registry last updated
Apr 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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