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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035869
Receipt No. R000040850
Scientific Title Phase I and II trial of combination therapy using nab-Paclitaxel+Pertuzumab+Trastuzumab for HER2 positive metastatic breast cancer
Date of disclosure of the study information 2019/04/01
Last modified on 2019/02/13

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Basic information
Public title Phase I and II trial of combination therapy using nab-Paclitaxel+Pertuzumab+Trastuzumab for HER2 positive metastatic breast cancer
Acronym Combination therapy of nab-Paclitaxel+Pertuzumab+Trastuzumab
Scientific Title Phase I and II trial of combination therapy using nab-Paclitaxel+Pertuzumab+Trastuzumab for HER2 positive metastatic breast cancer
Scientific Title:Acronym Combination therapy of nab-Paclitaxel+Pertuzumab+Trastuzumab
Region
Japan

Condition
Condition metastatic breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of safety and efficacy of combination therapy using nab-Paclitaxel+Pertuzumab+Trastuzumab for HER2 positive metastatic breast cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes time to treatment failure
Key secondary outcomes safety(after the first cycle)
response rate (best effect)

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 Treatment with nab-Paclitaxel (260mg/m2, q3w), Pertuzumab (840mg followed by 420mg, q3w) and Trastuzumab (8mg/kg followed by 6mg/kg, q3w)
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 or cytologically confirmed locally advanced breast cancer or metastatic breast cancer
2.Primary or metastatic region is HER2 positive: either 3+ over-expression by IHC or positive by FISH
3.With or without evaluable lesion
4.Female between 20 and 75 years old
5.Baseline left ventricular ejection fraction (LVEF) is >50% measured by echocardiography or MUGA scan.
6.PS: 0-2 (ECOG)
7.Expected survival time more than 6 months
8.Signed written informed consent
Key exclusion criteria 1.Without previous chemotherapy
2.With brain metastasis with symptom
3.With active another cancer
4.With uncontrollable hypertension, angina pectoris, congestive heart failure, myocardial infection within 6 months, arrhythmia that need treat, valvular heart disease
5.With dyspnea at rest due to metastatic lung lesion
6.Insufficient organ function meeting following criteria
Neutrophil <1500/mm2
Platelet <100000/mm2
Hemoglobin <8.0g/dL
AST(GOT)>100IU/L (with liver function disorder by metastasis)
ALT (GPT) >100IU/L (with liver function disorder by metastasis)
Serum total bilirubin <2.0mg/dL
Serum creatinine >2.0mg/dL or 177umol/L
7.With uncontrollable systemic disease (cardiovascular/pulmonary/metabolic, protracted wound healing, ulcer and bone fracture)
8.With uncontrollable hypercalcemia even by Bisphosphonate or denosumab
9.Pregnant or nursing women
10.Infection or possible infection associated with clinical symptoms
11.With history of hypersensitivity reaction for paclitaxel, trastuzumab, and pertuzumab.
12.Cases who physician judged improper to entry this trial
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Tangoku
Organization The University of Tokushima Graduate School
Division name Depertment of Thoracic, Endocrine surgery and Oncology, Institute of Health Bioscience
Zip code
Address 3-18-15 Kuramoto-cho, Tokushima City, Tokushima, 770-8503, Japan
TEL 088-633-7143
Email tangoku@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masami Morimoto
Organization The University of Tokushima Graduate School
Division name Depertment of Thoracic, Endocrine surgery and Oncology, Institute of Health Bioscience
Zip code
Address 3-18-15 Kuramoto-cho, Tokushima City, Tokushima, 770-8503, Japan
TEL 088-633-7143
Homepage URL
Email twop8air@tokushima-u.ac.jp

Sponsor
Institute The University of Tokushima Graduate School, Depertment of Thoracic, Endocrine surgery and Oncology, Institute of Health Bioscience
Institute
Department

Funding Source
Organization The University of Tokushima Graduate School, Depertment of Thoracic, Endocrine surgery and Oncology, Institute of Health Bioscience
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
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
2019 Year 04 Month 01 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
2019 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date
2019 Year 04 Month 01 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
2019 Year 02 Month 13 Day
Last modified on
2019 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040850

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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