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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030783
Receipt No. R000034485
Scientific Title A phase III study comparing T-DM1 with pertuzumab, trastuzumab and docetaxel in elderly patients with advanced stage HER2 positive breast cancer (JCOG1607, HERB TEA study)
Date of disclosure of the study information 2018/01/12
Last modified on 2018/01/12

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Basic information
Public title A phase III study comparing T-DM1 with pertuzumab, trastuzumab and docetaxel in elderly patients with advanced stage HER2 positive breast cancer (JCOG1607, HERB TEA study)
Acronym A phase III study comparing T-DM1 with pertuzumab, trastuzumab and docetaxel in elderly patients with advanced stage HER2 positive breast cancer (JCOG1607, HERB TEA study)
Scientific Title A phase III study comparing T-DM1 with pertuzumab, trastuzumab and docetaxel in elderly patients with advanced stage HER2 positive breast cancer (JCOG1607, HERB TEA study)
Scientific Title:Acronym A phase III study comparing T-DM1 with pertuzumab, trastuzumab and docetaxel in elderly patients with advanced stage HER2 positive breast cancer (JCOG1607, HERB TEA study)
Region
Japan

Condition
Condition HER2 positive advanced breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Randomized phase 3 trial to investigate non-inferiority of T-DM1 to combination therapy with trasutuzumab, pertuzumab and docetaxel in elderly patients with HER2-positive advanced breast cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Overall survival
Key secondary outcomes Progression-free survival, cumulative breast cancer specific survival, overall response rate, adverse events, serious adverse events, proportion of non-deteriorating of instrumental activities of daily living

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A: Trastuzumab (6 mg/kg, loading dose 8 mg/kg) + Pertuzumab (420 mg, loading dose 840 mg) + Docetaxel 60 mg/m2 q3w until Progression Disease (PD)
Interventions/Control_2 B: T-DM1 (3.6 mg/kg) q3w until PD
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
65 years-old <=
Age-upper limit
79 years-old >=
Gender Female
Key inclusion criteria 1) Histologically proven breast cancer (invasive cancer).
2) Histologically proven HER2 positive. Presense/absence of overexpression of estrogen receptor (ER) was examined.
3) Advanced breast cancer with distant metastatsis.
4) Women aged 65 to 79 years old.
5) ECOG performance status (PS) of 0 or 1 for 65 to 74 years old and 0 to 2 for 75 to 79 years old.
6) A measurable lesion is not required.
7) No active brain metastasis requiring therapy.
8) Neither prior chemotherapy (cytotoxic drug) or prior anti-HER2 therapy (trastuzumab, lapatinib, pertuzumab or T-DM1) for advanced breast cancer.
9) Adequate baseline laboratory data within 14 days prior to registration:
1. neutrophil count >= 1,500 /mm3
2. hemogrobin >= 9.0mg/dL without blood transfution within 14 days
3. platelet count >= 100,000 /mm3
4. total bilirubin <= 1.5 mg/dL
5. AST <= 100 U/L
6. ALT <= 100 U/L
7. serum creatinin <= 1.2 mg/dL
10) Left ventricular ejection fraction (LVEF) >= 50% by newest cardiography
11) Written informed consent.
Key exclusion criteria 1. Simultaneous or metachronouss (within 5 years) malignancy except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers.
2. Active infection requiring systemic therapy.
3. Body temperature of 38.0 degrees Celsius or higher.
4. Severe psychiatric diseases.
5. Patients requiring systemic steroid medication or the other immunosuppressive drug.
6. Poorly controlled diabetes mellitus.
7. Poorly controlled hypertension.
8. Unstable angina pectoris or history of myocardial infarction within 6 months.
9. Poorly controlled valve disease, dilated or hypertrophic cardiomyopathy.
10. HBs antigen positive
Target sample size 330

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Tamura
Organization National Cancer Center Hospital
Division name Department of Breast and Medical Oncology
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan
TEL 03-3542-2511
Email ketamura@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiko Shimomura
Organization JCOG1607 Coordinating Office
Division name Department of Breast and Medical Oncology
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan
TEL 03-3542-2511
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization National Cancer Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 国立病院機構北海道がんセンター(北海道)
岩手医科大学(岩手県)
東北大学病院(宮城県)
筑波大学医学医療系(茨城県)
自治医科大学(栃木県)
群馬県立がんセンター(群馬県)
埼玉県立がんセンター(埼玉県)
国立がん研究センター東病院(千葉県)
千葉県がんセンター(千葉県)
国立がん研究センター中央病院(東京都)
がん・感染症センター都立駒込病院(東京都)
国立病院機構東京医療センター(東京都)
昭和大学病院(東京都)
がん研究会有明病院(東京都)
虎の門病院(東京都)
聖路加国際病院(東京都)
東海大学医学部(神奈川県)
聖マリアンナ医科大学(神奈川県)
神奈川県立がんセンター(神奈川県)
北里大学医学部(神奈川県)
横浜労災病院(神奈川県)
新潟県立がんセンター新潟病院(新潟県)
静岡県立総合病院(静岡県)
静岡県立静岡がんセンター(静岡県)
愛知県がんセンター中央病院(愛知県)
国立病院機構名古屋医療センター(愛知県)
名古屋市立大学病院(愛知県)
近畿大学医学部(大阪府)
大阪国際がんセンター(大阪府)
国立病院機構大阪医療センター(大阪府)
岡山大学病院(岡山県)
国立病院機構呉医療センター・中国がんセンター(広島県)
広島大学病院(広島県)
広島市立広島市民病院(広島県)
国立病院機構福山医療センター(広島県)
広島市立安佐市民病院(広島県)
国立病院機構四国がんセンター(愛媛県)
国立病院機構九州がんセンター(福岡県)
北九州市立医療センター(福岡県)
国立病院機構長崎医療センター(長崎県)
熊本大学医学部(熊本県)
博愛会相良病院(鹿児島県)

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 12 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
2017 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 12 Day
Last follow-up date
2030 Year 07 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 12 Day
Last modified on
2018 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034485

Research Plan
Registered date File name

Research case data specifications
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Research case data
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