UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045181 |
|---|---|
| Receipt number | R000051617 |
| Scientific Title | The Preferred Premedication Order to Prevent Infusion Reactions in Patients with Breast Cancer Receiving Pertuzumab plus Trastuzumab and Docetaxel |
| Date of disclosure of the study information | 2021/08/18 |
| Last modified on | 2022/03/11 16:50:50 |
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Basic information
Public title
The Preferred Premedication Order to Prevent Infusion Reactions in Patients with Breast Cancer Receiving Pertuzumab plus Trastuzumab and Docetaxel
Acronym
The Preferred Premedication Order to Prevent Infusion Reactions in Patients with Breast Cancer Receiving Pertuzumab plus Trastuzumab and Docetaxel
Scientific Title
The Preferred Premedication Order to Prevent Infusion Reactions in Patients with Breast Cancer Receiving Pertuzumab plus Trastuzumab and Docetaxel
Scientific Title:Acronym
Prophylaxis for Infusion Reactions in Pertuzumab plus Trastuzumab and Docetaxel
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study evaluated the ability of premedication to prevent infusion reactions following treatment with pertuzumab, trastuzumab, and docetaxel.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of infusion reactions
Key secondary outcomes
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Dexamethasone 6.6mg
Pertuzumab 840mg
Trastuzumab 8mg/kg
Docetaxel 75mg/m2
Interventions/Control_2
Pertuzumab 840mg
Trastuzumab 8mg/kg
Dexamethasone 6.6mg
Docetaxel 75mg/m2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Female patients with histologically confirmed invasive breast cancer
2) No prior treatment with anti-HER2 therapy for breast cancer
3) HER2-positive
4) Any ER, PR. and Ki67-LI are allowed
5) No significant abnormal EKG
6) History of breast cancer and synchronous bilateral breast cancer are allowed unless anti-HER2 therapy was administrated
7) ECOG PS 0-1
8) Sufficient organ function confirmed with following major examination
WBC>=3000/mm3 or ANC 1.500
Plt>=100000/mm3
Hb>=9.0g/dL
T-Bil<=1.5mg/dL
AST,ALT<=2.5 times ULN
Cre<=1.5mg/dL
No concurrent treatment for cerebral infarction at the registration
No history of myocardial infarction and congestive heart failure
9) Operable primary breast cancer
10) Written informed consent
Key exclusion criteria
1) Serious drug hypersensitivity
2) Pregnant or lactation women, or women with suspected pregnancy
3) Other any cancer
4) Other severe complications
AMI, heart failure, purmonary fibrosis, uncontrolled DM, severe infection and so on
5) Severe mental disorders
6) Active bleeding of digestive tract
7) Serious myeloablation, renal insufficciency, liver failure
8) Diarrhea
9) Active infection
10) Prior treatment with anti-HER2 therapy for breast cancer
11) Metastatic breast cancer
12) Under treatment with continuous systemic steroid, anti-allergic agent, anti-histamine agent, immunosuppresant, and NSAID
13) Not suitable for participating in the study for any other reason
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ryoichi |
| Middle name | |
| Last name | Matsunuma |
Organization
Shizuoka General Hospital
Division name
Department of Breast Surgery
Zip code
420-8527
Address
4-27-1 Kita-Ando Aoi-ku Shizuoka 420-8527, Japan
TEL
0542476111
r-matsunuma@nifty.com
Public contact
Name of contact person
| 1st name | Shigeru |
| Middle name | |
| Last name | Nakagaki |
Organization
Shizuoka General Hospital
Division name
Department of Pharmacy
Zip code
420-8527
Address
4-27-1 Kita-Ando Aoi-ku Shizuoka 420-8527, Japan
TEL
0542476111
Homepage URL
e-drug@gb3.so-net.ne.jp
Sponsor or person
Institute
Shizuoka Prefectural Hospital Organization, Shizuoka General Hospital
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Shizuoka General Hospital
Address
4-27-1 Kita-Ando Aoi-ku Shizuoka 420-8527, Japan
Tel
0542476111
chiken-sougou@shizuoka-pho.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 | 08 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 18 | Day |
Last modified on
| 2022 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051617
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
