Unique ID issued by UMIN | UMIN000045432 |
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Receipt number | R000050794 |
Scientific Title | LIBRA trial: A Randomized trial to assess clinical utility of LINE-electronic patient reported outcomes for the management of adverse events in breast cancer patients treated with abemaciclib |
Date of disclosure of the study information | 2021/09/13 |
Last modified on | 2024/03/21 10:31:57 |
LIBRA trial: A Randomized trial to assess clinical utility of LINE-electronic patient reported outcomes for the management of adverse events in breast cancer patients treated with abemaciclib
LIBRA trial
LIBRA trial: A Randomized trial to assess clinical utility of LINE-electronic patient reported outcomes for the management of adverse events in breast cancer patients treated with abemaciclib
LIBRA trial
Japan |
Breast Cancer
Breast surgery |
Malignancy
NO
In patients receiving abemaciclib for advanced metastatic breast cancer, diarrhea, which is a particularly frequent side effect, will be monitored using the PRO reporting system, and intervention will be conducted with and without advice from expert nurses.
Others
Management of adverse events, QOL
Exploratory
The number of stools increased from baseline per day will be recorded by the LINE-ePRO system during one cycle of abemaciclib treatment (28 days). The sum of the number of bowel movements over 28 days is defined as the AUC. The AUC during 1 cycle will be defined as the primary endpoint.
a) AUC during 2 cycles of abemaciclib treatment
b) QOL
The EQ-5D-5L and EORTC QLQ-C30 will be used to confirm the results at three points: before administration, after one cycle of treatment, and six months later or at the end of abemaciclib treatment.
c) Relative dose intensity (RDI)
Evaluate the therapeutic intensity of the actual dose versus the standard dose over the 2 cycles (56 days) of abemaciclib treatment
d) Discontinuation rate
Frequency of abemaciclib discontinuation.
e) Progression free survival (PFS)
Progression-free survival with abemaciclib
f) Overall survival (OS)
Time from diagnosis of advanced breast cancer to death
g) Frequency of hospital inquiries and emergency visits
The frequency of telephone calls regarding symptoms will be assessed from the protocol start date to the end or discontinuation date. The frequency of unannounced visits and emergency room visits due to deterioration of physical condition will be evaluated. (Exclude paperwork and inquiries not directly related to symptoms or treatment.
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients aged 20 years or older with hormone receptor positive HER2 negative advanced breast cancer
2) Patients receiving treatment with abemaciclib + aromatase inhibitor +-leuprorelin or abemaciclib + fulvestrant +-leuprorelin
3) ECOG performance status 0 or 1
4) Patients who are considered capable of operating the smartphone and LINE application
5) If chemotherapy was administered in the previous treatment, the patient must have recovered, CTCAE Grade 1 or less, from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to randomization. A washout period of at least 21 days is required between last chemotherapy dose and randomization, provided the patient did not receive radiotherapy.
6) Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and randomization.
7) Patients who are able to swallow oral medications.
8) The patient has adequate organ function for all of the following criteria, as defined in Table 1 below.
Neutrophils 1.5x10^9 per L or more
Platelet 100x10^9 per L or more
Hemoglobin 8 g/dl or more
Treatment of anemia with red blood cell transfusion is acceptable at the discretion of the physician, but treatment should not be initiated prior to the date of transfusion administration.
Total bilirubin 1.5xULN or less
Total bilirubin 2.0xULN or less for Gilbert's syndrome, acceptable if direct bilirubin is normal
ALT, AST 3xULN or less
1) severe hepatic and renal dysfunction (eGFR <30ml/min)
2) interstitial lung disease or a history of the disease
3) dyspnea at rest or requiring oxygen administration
4) a history of administration of CDK4/6 inhibitors
5) preexisting Crohn's disease or ulcerative colitis
6) infectious diarrhea including hemorrhagic colitis or pseudomembranous enteritis
7) preexisting chronic condition resulting in baseline grade 2 or higher diarrhea
8) arrhythmia or uncontrolled heart failure in the past 6 months
9) preexisting ileus or potential condition that may result in ileus
10) history of major surgical resection involving the stomach or small bowel or patients with stoma
11) active systemic bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]. Screening is not required for enrollment.
12) personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
13) contraindicated in the label of abemaciclib; history of severe allergic reaction to abemaciclib.
14) contraindicated in the label of nonsteroidal aromatase inhibitors; females who are pregnant or lactating.
15) a history of allergic reaction to nonsteroidal aromatase inhibitors.
16) contraindicated in the label of loperamide; history of severe allergic reaction to loperamide.
17) not own smartphone or who are not capable of operating LINE application
60
1st name | Tetsu |
Middle name | Nagayama |
Last name | Hayashida |
Keio University School of Medicine
Department of Surgery
160-8582
35 Shinanomachi Shinjuku Tokyo Japan
0333531211
tetsu@keio.jp
1st name | Aiko |
Middle name | |
Last name | Nagayama |
Keio University School of Medicine
Department of Surgery
160-8582
35 Shinanomachi Shinjuku Tokyo Japan
0333531211
anagayama@keio.jp
Keio University School of Medicine
Eli Lilly Japan K.K.
Profit organization
Keio University School of Medicine Ethics Committee
Shinjukuku
0333531211
med-rinri-ft_pt@adst.keio.ac.jp
NO
2021 | Year | 09 | Month | 13 | Day |
Unpublished
No longer recruiting
2021 | Year | 09 | Month | 09 | Day |
2021 | Year | 09 | Month | 09 | Day |
2022 | Year | 01 | Month | 19 | Day |
2028 | Year | 01 | Month | 01 | Day |
2023 | Year | 09 | Month | 30 | Day |
After explaining about the study and obtaining consent, the subject will be issued an ID and password to log in to the app by the doctor in charge or research nurse. Using the ID and password, the subject will register for the designated application.
After the registration procedure is completed by the research office, the subjects will be randomly assigned to either the "intervention group" or the "non-intervention group". Subjects assigned to the "intervention group" will enter their daily symptoms into the app, and nurses will call them to check their symptoms and medication status when deemed necessary, such as when their symptoms worsen. Subjects assigned to the "non-intervention group" will enter their symptoms into the app as well, but in principle, the nurse will not call to check on their status. In both groups, the same method will be used in advance to explain what to do in case of side effects. In case of sudden worsening of symptoms, or worsening of symptoms on weekends, holidays, or at night, the subject herself will contact the hospital directly if she feels it necessary. The subject will be required to respond to the QOL survey as appropriate.
2021 | Year | 09 | Month | 09 | Day |
2024 | Year | 03 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050794
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