UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009108 |
|---|---|
| Receipt number | R000010681 |
| Scientific Title | A phase II neoadjuvant trial of concurrent trastuzumab, paclitaxel and endocrine therapy in women with HER2-positive and hormone receptor-positive breast cancer. |
| Date of disclosure of the study information | 2012/10/17 |
| Last modified on | 2024/03/21 11:16:16 |
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Basic information
Public title
A phase II neoadjuvant trial of concurrent trastuzumab, paclitaxel and endocrine therapy in women with HER2-positive and hormone receptor-positive breast cancer.
Acronym
HERPLET
Scientific Title
A phase II neoadjuvant trial of concurrent trastuzumab, paclitaxel and endocrine therapy in women with HER2-positive and hormone receptor-positive breast cancer.
Scientific Title:Acronym
HERPLET
Region
| Japan |
Condition
Condition
women with HER2-positive and hormone receptor-positive breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy and safety of trastuzumab and paclitaxel with endocrine therapy as neoadjuvant therapy for HER2-positive and hormone receptor-positve breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
clinical response rate, tumor reduction rate
Key secondary outcomes
pathological CR rate, adverse event, breast conserving rate, relapse free survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Eligible premenopausal women receive tamoxifen 20mg/d orally and trastuzumab is given with a loading dose of 4 mg/kg; subsequent doses are 2 mg/kg every week. In addition, paclitaxel is given at a dose of 80 mg/m2; every week for 12 weeks.
Eligible postmenopausal women receive letrozole 2.5mg/d orally and trastuzumab is given with a loading dose of 4 mg/kg; subsequent doses are 2 mg/kg every week. In addition, paclitaxel is given at a dose of 80 mg/m2; every week for 12 weeks.
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
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Histologically confirmed invasive breast cancer
2. ER and or PgR-positive, HER2-positive
3. Measurable disease
4. Stage I , II or III
5. Age at 20 or older and at 75 or younger.
6. Performance status 0 or 1
7. Untreated breast cancer
8. Meet the cirteria of baseline labolatory parameters as below.
1) WBC 3500/mm3 or more, 10000/mm3 or less, Plt 100,000/mm3 or more, Hb 10g/dl or more
2) T.Bil 1mg/dl or less, GOT 60 IU/L or less, GPT 60 IU/L or less
9. Written informed consent
Key exclusion criteria
1. Other active malignancies
2. Hemorrhagic diathesis
3. History of cardiac infarction, valvular diseases of the heart and severe cardiac disfunction
4. Liver cirrhosis
5. Other medical conditions that could limit a patient's ability to undertake study therapy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsu Hayashida |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
35 Shinanomachi Shinjuku, Tokyo, Japan
TEL
03-5363-3802
tetsu@z7.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsu Hayashida |
Organization
Keio University School of Medicine
Division name
Department of Surgery, breast group
Zip code
Address
35 Shinanomachi Shinjuku, Tokyo, Japan
TEL
03-5363-3802
Homepage URL
tetsu@z7.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 17 | 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
| 2012 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 04 | 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
| 2012 | Year | 10 | Month | 13 | Day |
Last modified on
| 2024 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010681
| Research Plan | |
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| Registered date | File name |
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