UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045432
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

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Basic information

Public 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

Acronym

LIBRA trial

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

Scientific Title:Acronym

LIBRA trial

Region

Japan


Condition

Condition

Breast Cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

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.

Basic objectives2

Others

Basic objectives -Others

Management of adverse events, QOL

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

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.

Key secondary outcomes

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.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

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

Key exclusion criteria

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

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Tetsu
Middle name Nagayama
Last name Hayashida

Organization

Keio University School of Medicine

Division name

Department of Surgery

Zip code

160-8582

Address

35 Shinanomachi Shinjuku Tokyo Japan

TEL

0333531211

Email

tetsu@keio.jp


Public contact

Name of contact person

1st name Aiko
Middle name
Last name Nagayama

Organization

Keio University School of Medicine

Division name

Department of Surgery

Zip code

160-8582

Address

35 Shinanomachi Shinjuku Tokyo Japan

TEL

0333531211

Homepage URL


Email

anagayama@keio.jp


Sponsor or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Eli Lilly Japan K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Keio University School of Medicine Ethics Committee

Address

Shinjukuku

Tel

0333531211

Email

med-rinri-ft_pt@adst.keio.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2021 Year 09 Month 13 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2021 Year 09 Month 09 Day

Date of IRB

2021 Year 09 Month 09 Day

Anticipated trial start date

2022 Year 01 Month 19 Day

Last follow-up date

2028 Year 01 Month 01 Day

Date of closure to data entry


Date trial data considered complete

2023 Year 09 Month 30 Day

Date analysis concluded



Other

Other related information

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.


Management information

Registered date

2021 Year 09 Month 09 Day

Last modified on

2024 Year 03 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050794


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name