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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009108
Receipt No. 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 2017/04/18

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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
Email 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
Email tetsu@z7.keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

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
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

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 Open public recruiting
Date of protocol fixation
2012 Year 10 Month 13 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 17 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
2012 Year 10 Month 13 Day
Last modified on
2017 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010681

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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