UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory study evaluating efficacy and safety of hangeshashinto for treatment of Everolimus-associated stomatitis in patients with breast cancer.
Title of the study (Brief title)	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	Yayoi Honda
Organization	Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital
Division name	Breast surgery
Address	3-18-22 Honkomagome, Bunkyo-ku,Tokyo
TEL	03-3823-2101
Email	yayoi.honda@cick.jp

Public contact
Name of contact person	Yayoi Honda
Organization	Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital
Division name	Breast surgery
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 01 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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