UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of q3w nab-paclitaxel in combination with q3w trastuzumab for HER2 positive metastatic breast cancer.
Acronym	Nature study
Scientific Title	Phase II study of q3w nab-paclitaxel in combination with q3w trastuzumab for HER2 positive metastatic breast cancer.
Scientific Title:Acronym	Nature study
Region	Japan

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

Objectives
Narrative objectives1	Evaluation of the effficacy and safety of q3w nab-paclitaxel in combination with q3w trastuzumab for HER2 positive metastatic breast cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Progression-free survival Safety Overall survival

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	Abraxane: 260mg/m2, iv, day 1 Every 3 weeks Trastuzumab: 6mg/kg, iv, day1 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	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1. Histologically confirmed metastatic breast cancer. 2. Age are more than 20 years old 3. within withiin 2 prior treatment for metastatic breast cancer. 4. With evaluable leasion 5. Performance statu is 0,1,2. 6. Required baseline laboratory data. (within 14 days of registration) WBC > 4,000 /mm3 or Neu > 2,000/mm3 PLT > 100,000 /mm3 Hb > 9.0 g/dL ALT and AST < ULNx2.5 ALT and AST < ULNx2.5 T-Bil < 1.5mg/dL serum creatine < 1.5mg/dL 7. Expected survival time: more than 6 months. 8.Written informed- consent
Key exclusion criteria	1. With history of hypersensitivity reaction for paclitaxel and/or albumin and/or trastuzumab. 2. With severe complications. 3. Pregnant or nursing women. 4. With widespread liver metastases or with dyspnea in pulmonary lymphangitis. 5. With severe complications. 6. With brain metastasis. 7. with uncontrollable hypertension, angina, congestive heart failure, myocardial infection within 1 year, arrhythmia, valvular heart disease. 8. With pulmonary fibrosis or pneumonitis. 9. With dyspnea at rest. 10. With pleural effusion, ascites, pericardial effusion. 11. Doctor's decision not to be registered to this study.
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Middle name Last name Seiichi Takenoshita
Organization	Fukushima Medical University School of medicine
Division name	Department of Surgery
Zip code
Address	1 Hikariga-oka, Fukushima
TEL	024-547-1259
Email

Public contact
Name of contact person	1st name Middle name Last name Tohru Ohtake
Organization	Fukushima Medical University School of medicine
Division name	Department of Surgery, Division of Breast Surgery
Zip code
Address	1 Hikariga-oka, Fukushima
TEL	024-547-1259
Homepage URL
Email	trcyn@cc.fmu.ac.jp

Sponsor
Institute	Fukushima Medical University School of medicine
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	公立大学法人福島県立医科大学附属病院

Other administrative information
Date of disclosure of the study information	2011 Year 10 Month 16 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	2011 Year 09 Month 30 Day
Date of IRB	2017 Year 04 Month 28 Day
Anticipated trial start date	2011 Year 10 Month 01 Day
Last follow-up date	2018 Year 03 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	2011 Year 10 Month 16 Day
Last modified on	2019 Year 10 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007757