An observational study in Breast Cancer Patients and Therapy Related Tumor, sponsored by Centre Jean Perrin. Completed at 5 sites in France. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-04-05.
Sponsored by Centre Jean Perrin · Observational
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 97 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Centre Jean Perrin is the lead sponsor of 55 studies on the registry; 9 are open to participants now.
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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
Exclusion Criteria:
Data collection
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
Time frame: 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
Time frame: 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
Time frame: 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®
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: up to at least 6 months after Halaven® start
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.
Time frame: up to at least 6 months after Halaven® start
-Evaluate the percentage of patients with hepatic metastases
-Percentage of liver metastatic patients
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®
-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®
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.
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
-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
Time frame: 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).
Time frame: 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.
Time frame: up to at least 6 months after Halaven® start
Plan to share: No
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