UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016109 |
|---|---|
| Receipt number | R000018713 |
| Scientific Title | Evaluation of Oral Care in preventing Oral Mucositis in Estrogen Receptor Positive Metastatic Breast Cancer Patients Treated with Everolimus: Randomized Controlled Phase III Trial |
| Date of disclosure of the study information | 2015/01/05 |
| Last modified on | 2019/10/18 13:46:57 |
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Basic information
Public title
Evaluation of Oral Care in preventing Oral Mucositis in Estrogen Receptor Positive Metastatic Breast Cancer Patients Treated with Everolimus: Randomized Controlled Phase III Trial
Acronym
Oral Care-BC
Scientific Title
Evaluation of Oral Care in preventing Oral Mucositis in Estrogen Receptor Positive Metastatic Breast Cancer Patients Treated with Everolimus: Randomized Controlled Phase III Trial
Scientific Title:Acronym
Oral Care-BC
Region
| Japan |
Condition
Condition
Metastatic or recurrent breast cancer
Classification by specialty
| Breast surgery | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine whether the occurrence of stomatitis can be reduced by dental oral management in patients by the comparison of dental oral management by instruction from dental oral surgeons and an observation group in a randomized, controlled study in female patients using everolimus for estrogen receptor-positive, hormone therapy-resistant or -refractory breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Incidence of stomatitis in over Grade 1 after everolimus treatment (evaluated by a cancer treatment doctor)
Key secondary outcomes
Each incidence of stomatitis in over Grade 2, or over Grade 3, (evaluated by a cancer treatment doctor)
Each incidence of stomatitis in over Grade 1, over Grade 2 or over Grade 3 (evaluated by a cancer treatment doctor)
Time to first occurrence of stomatitis
Duration of each Grade of stomatitis
Each ratio of patients in suspension, or
dose-reduction of everolimus treatment due to stomatitis
Oral Assessment Guide (Revised)1
Health-related quality of life(HRQOL)
Time to treatment failure (TTF)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Everolimus treatment
Interventions/Control_2
dental oral management
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)Female patient with a histological diagnosis of breast cancer.
2)Inoperable metastatic breast cancer, or metastatic progression/recurrent breast cancer after surgical operation.
3) Patient confirmed histologically to have ER-positive breast cancer.
4)Postmenopause
5)Any of the below conditions indicating resistance to aromatase inhibitor ;
a)Recurrent breast cancer ; Recurrence during adjuvant therapy of aromatase inhibitor, or after the therapy within 12 months or below.
b)Advanced breast cancer ; Progression during the treatment using aromatase inhibitor, or after the treatment within a month or below.
6)Any number of chemotherapy (anti-neoplastic drugs) are allowed since diagnosis of metastatic or recurrent breast cancer.
7) Aged >=20 years
8)ECOG Performance Status: 0 or 1
9)Previous treatment (including adjuvant therapy) satisfies all of below.
a)Hormone therapy: At least 7 days have elapsed from last day of hormone therapy before the beginning of this protocol therapy.
b)Radiation therapy: At least 14 days have elapsed from last day of irradiation before the beginning of this protocol therapy.
10)Organ function (within 4 weeks before enrollment)
a)ANC >=1,500/mm3, or WBC >=3,000/mm3
b)Platelet count >=100,000/mm3
c)Total bilirubin <=2.5 times of ULN
d)AST(GOT) and ALT(GPT) <=2.5 times of ULN
e)Serum creatinine <=1.5 times of ULN
(Upper limit of normal)
11)Others, Cardiac function
12)Written Informed Consent
Key exclusion criteria
1)Toothless jaw
2)Occurrence of stomatitis within 1 month prior to randomization
3)Chemotherapy used within 1 month prior to randomization
4)Exemestane monotherapy used just before the randomization (this is not met, if this therapy has not been used for over 3 months before randomization)
5) Previous mTOR inhibitor treatment (everolimus, etc.)
6)Interstitial pneumonia or pulmonary fibrosis.
7)Treatment with drugs, which are known to have a strong inhibitory or inductive effect on the cytochrome P450 (CYP) 3A isozymes, within 5 days prior to randomization. The dugs are shown below ; rifabutin, rifampicin, clarithromycin, ketoconazole, voriconazole, ritonavir, telithromycin
8)HBs antigen positive, and HBc antibody and/or HBs antibody positive.
9)HCV infection, or a history of HCV infection.
10)History of hypersensitivity to a protocol treatment drug or a vehicle in the drug preparation.
11)Multiple active cancers (homochronous multiple cancers, or heterochronous multiple cancers with a disease-free period of less than 5 years prior to randomization).
12)HER2 overexpression (Her2/neu, Erb B2), and requirement of trastuzumab (herceptin) treatment. In other words, patients that satisfy any of the below conditions will be excluded.
At either the primary lesion or the metastatic lesion:
a)Strongly Positive (3+) by HER2 immunohistochemical (IHC) test.
b)Positive (+) by FISH (fluorescence in situ hybridization).
13)Brain metastasis that requires intracranial hypertension or emergency irradiation of the brain.
14)Extensive liver metastasis, or lymphangitic lung metastasis with accompanying dyspnea.
15)Pleural effusion, ascites, or pericardial effusion that requires emergency treatment.
16)Active infectious disease.
17)Uncontrolled diabetes mellitus or diabetes currently receiving insulin therapy.
18)Study participation is difficult due to mental illness or psychiatric symptoms.
19)Unable to participate the trial by an investigator's judgment
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Niikura (1), Yoshihide Ohta (2) |
Organization
(1)(2)Tokai University School of Medicine
Division name
(1)Departments of Breast and Endocrine Surgery, (2)Departments of Dentistry and Oral and Maxillofacial Surgery
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa, 259-1193 Japan
TEL
0463-93-1121
niikura@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Yamao |
Organization
Public Health Research Foundation
Division name
Comprehensive Support Project for Oncology Research
Zip code
Address
1-1-7, Nishiwaseda, Shinjyuku-ku Tokyo, 169-0051 JAPAN
TEL
03-5287-2636
Homepage URL
http://www.csp.or.jp/
support@csp.or.jp
Sponsor or person
Institute
Oral Care-BC executive committee
Institute
Department
Personal name
Funding Source
Organization
Novartis International AG
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
愛知県がんセンター中央病院、朝日大学歯学部附属村上記念病院、大阪医療センター、大阪市立大学医学部附属病院、太田記念病院、神奈川県立がんセンター、川崎医科大学附属病院、がん感染症センター都立駒込病院、岐阜市民病院、京都府立医科大学附属病院、くまもと森都総合病院、群馬県立がんセンター、神戸市立医療センター中央市民病院、国立がん研究センター東病院、さいたま赤十字病院、札幌医科大学附属病院、四国がんセンター、静岡県立総合病院、渋川医療センター・石田歯科医院、千葉大学医学部附属病院、手稲渓仁会病院、東海大学医学部付属病院、長崎原爆病院、長崎大学病院、名古屋市立大学病院、浜松医療センター、浜松オンコロジーセンター・あがた歯科、兵庫医科大学病院、広島市立広島市民病院、北海道がんセンター、りんくう総合医療センター
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 05 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 16 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 16 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 05 | Day |
Last modified on
| 2019 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018713
