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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000012452
Receipt No. R000014567
Scientific Title Phase II Trial of Pertuzumab plus Trastuzumab plus Docetaxel for HER2-Positive Metastatic Breast Cancer that Progressed During Prior Trastuzumab Therapy
Date of disclosure of the study information 2013/12/02
Last modified on 2018/12/04

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Basic information
Public title Phase II Trial of Pertuzumab plus Trastuzumab plus Docetaxel for HER2-Positive Metastatic Breast Cancer that Progressed During Prior Trastuzumab Therapy
Acronym Phase II Trial of Pertuzumab plus Trastuzumab plus Docetaxel for HER2-Positive Metastatic Breast Cancer that Progressed During Prior Trastuzumab Therapy
(CYBORG-002)
Scientific Title Phase II Trial of Pertuzumab plus Trastuzumab plus Docetaxel for HER2-Positive Metastatic Breast Cancer that Progressed During Prior Trastuzumab Therapy
Scientific Title:Acronym Phase II Trial of Pertuzumab plus Trastuzumab plus Docetaxel for HER2-Positive Metastatic Breast Cancer that Progressed During Prior Trastuzumab Therapy
(CYBORG-002)
Region
Japan

Condition
Condition HER2-Positive Metastatic Breast Cancer
Classification by specialty
Breast surgery Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose is to assess the efficacy and the safety of pertuzumab plus trastuzumab plus docetaxel for HER2 positive metastatic breast cancer that progressed during prior trastuzumab therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Objective response rate
Key secondary outcomes Progression free survival
Clinical benefit rate
Overall survival
Safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of Pertuzumab and Trastuzumab with a starting dose of 840 mg and 8 mg/kg followed by 420 mg and 6 mg/kg as the second and subsequent doses and Docetaxel with a dose of 60-75 mg/m2 every 3 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
18 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1. Patients who are 18 years or older with breast cancer which is confirmed to be invasive breast cancer by histological examination
2. HER2(3+) by immunohistochemical or positive by fluorescence in situ hybridization methods
3. ECOG performance status(PS) is 0, 1 or 2
4. Patients with measurable lesions by Response Evaluation Criteria In Solid Tumors (RECIST)
5. The number of prior trastuzumab therapy is within 3 regimen.
6. Major organ function is maintained.
7. Left-ventricular ejection fraction (LVEF) is at least 50% at baseline.
8. Signed informed consent was obtained from patient.
Key exclusion criteria 1. Patients who have an active infection or high fever with suspicious infection.
2. Patients who have a history of cardiac disease, including known symptomatic decreases in LVEF to less than 50% absolute value during prior trastuzumab therapy or congestive heart failure.
3. Patients with pulmonary fibrosis or interstitial pneumonia that is clear from the chest X-ray
4. Patients with previous exposure to a cumulative dose of doxorubicin of more than 360 mg/m2
5. Patients with a decline in LVEF to less than 50% during or after former trastuzumab treatment
6. Patients suspected of being pregnant or pregnant women
7. Patients with another malignancy within the last 5 years
8. Patients with uncontrollable brain metastases
9. Patients who were considered by the primary care physician to be inappropriate as subjects of this trial
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin Takayama
Organization Tokyo Dental College Ichikawa General Hospital
Division name Department of Surgery
Zip code
Address 5-11-13 Sugano, Ichikawa-shi, Chiba, JAPAN
TEL 047-322-0151
Email stakayama@tdc.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mutsumi Ishi
Organization Tokyo Dental College Ichikawa General Hospital
Division name Department of Pharmacy
Zip code
Address 5-11-13 Sugano, Ichikawa-shi, Chiba, JAPAN
TEL 047-322-0151
Homepage URL
Email mishii@tdc.ac.jp

Sponsor
Institute Chiba Youth Breast Oncology Research Group (CYBORG)
Institute
Department

Funding Source
Organization None
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 1)亀田総合病院(千葉県)
2)東京歯科大学市川総合病院(千葉県)
3)千葉県がんセンター(千葉県)
4)千葉大学医学部付属病院(千葉県)

Other administrative information
Date of disclosure of the study information
2013 Year 12 Month 02 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
2013 Year 10 Month 02 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 26 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 12 Month 01 Day
Last modified on
2018 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014567

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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