UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031196
Receipt number 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 15:00:24

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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 or person

Institute

Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital

Institute

Department

Personal name



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

Value
https://center6.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