UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I and II trial of combination therapy using nab-Paclitaxel+Pertuzumab+Trastuzumab for HER2 positive metastatic breast cancer
Title of the study (Brief title)	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	Akira Tangoku
Organization	The University of Tokushima Graduate School
Division name	Depertment of Thoracic, Endocrine surgery and Oncology, Institute of Health Bioscience
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	Masami Morimoto
Organization	The University of Tokushima Graduate School
Division name	Depertment of Thoracic, Endocrine surgery and Oncology, Institute of Health Bioscience
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 02 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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