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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000031196
Receipt No. R000035477
Scientific Title Exploratory study evaluating efficacy and safety of hangeshashinto for treatment of Everolimus-associated stomatitis in patients with breast cancer.
Date of disclosure of the study information 2018/03/31
Last modified on 2018/06/22

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Basic information
Public title Exploratory study evaluating efficacy and safety of hangeshashinto for treatment of Everolimus-associated stomatitis in patients with breast cancer.
Acronym Exploratory study evaluating efficacy and safety of hangeshashinto for treatment of Everolimus-associated stomatitis in patients with breast cancer.
Scientific Title Exploratory study evaluating efficacy and safety of hangeshashinto for treatment of Everolimus-associated stomatitis in patients with breast cancer.
Scientific Title:Acronym Exploratory study evaluating efficacy and safety of hangeshashinto for treatment of Everolimus-associated stomatitis in patients with breast cancer.
Region
Japan

Condition
Condition Stomatitis
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of hangeshashinto for the treatment of Everolimus-associated stomatitis, compared with historical controls from BOLERO-2 trial.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The incidence of greater than or equal to grade2(CTCAE ver4.0) stomatitis within 8 weeks after start of Everolimus administration
Key secondary outcomes 1)The incidence of each grade stomatitis
in 8 weeks after Everolimus administration
2)Rate of Everolimus dose adjustment or discontinuation
3)Adverse event other than stomatitis

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral administration of 2.5 g hangeshashinto three times a day for 8 weeks after onset of stomatitis
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 Female
Key inclusion criteria 1) Metastatic or locally recurrent unresectable breast cancer
2) Histological or cytological confirmation of hormone-receptor positive (HR+) human epidermal growth factor receptor 2 negative (HER2-) breast cancer
3) Patients who are scheduled to initiate treatment with everolimus (10mg) once a
day
4) ECOG Performance Status of 0-2
5) Postmenopausal
6) Adequate bone marrow, liver and renal function before start of Everolimus administration
7) Baseline absence of oral stomatitis
8) Patients who are expected to survive more than 16 weeks at the time of acquiring consent
9) Asian
10) Age: >= 20 years
11) Capability of oral administration
12) Written informed consent
Key exclusion criteria 1) Patients who have received radiotherapy or chemotherapy
2) Known intolerance or hypersensitivity to everolimus or other rapamycin analogs
3) Known impairment of gastrointestinal (GI) function or GI disease
4) Diabetic patients HbA1c >8%(without patients who have an anamnestic history)
5) Patients who have any uncontrolled medical conditions such as
-Unstable angina pectoris, Symptomatic congestive heart failure of New York heart Association Class III or IV, myocardial infarction or any other clinically significant cardiac disease <= 6 months prior to start of Everolimus administration
-Active or severe infection
-Interstitial pneumonia, pulmonary or fibrosis accompanying dyspnea
6) Patients who received live attenuated vaccines within 1 week of start of Everolimus administration and during the study
7) Patients who have a history of another primary malignancy(Carcinoma in situ deemed to be cured by local treatment (lesions that are intraepithelial carcinoma or mucosal cancer) is not included)
8) Brain metastasis that requires treatment for intracranial hypertension or emergency irradiation of the brain
9) Pleural effusion, ascites, or pericardial effusion that requires emergency treatment
10) Patients who have not had resolution of prior anti-cancer therapy to NCI CTCAE version 4.0 Grade 1
11) Difficulty to participate in this study due to mental illness or psychiatric symptoms
12) Patients who took prohibited medicines or the investigational drug within 4 weeks before enrollment
13) Patients who participated in another study within 4 weeks before enrollment
14) Patients who are pregnancy, possibly pregnancy, considering pregnancy or lactating
15) Patients who are allergic to Kampo medicine
16) Patients who are determined not applicable for the study by the physicians



Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yayoi Honda
Organization Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital
Division name Breast surgery
Zip code
Address 3-18-22 Honkomagome, Bunkyo-ku,Tokyo
TEL 03-3823-2101
Email yayoi.honda@cick.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yayoi Honda
Organization Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital
Division name Breast surgery
Zip code
Address 3-18-22 Honkomagome, Bunkyo-ku,Tokyo
TEL 03-3823-2101
Homepage URL
Email yayoi.honda@cick.jp

Sponsor
Institute Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital
Institute
Department

Funding Source
Organization TSUMURA & CO.
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
Address
Tel
Email

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 がん・感染症センター東京都立駒込病院(東京都)、虎の門病院(東京都)、東京都立多摩総合医療センター(東京都)、東京医科大学病院(東京都)、東邦大学医療センター大森病院(東京都)、聖マリアンナ医科大学病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 31 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 Terminated
Date of protocol fixation
2018 Year 01 Month 16 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 08 Day
Last modified on
2018 Year 06 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035477

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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