UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II trial of Trastuzumab in combination with Abraxane for patients with HER2-positive metastatic breast cancer
Title of the study (Brief title)	Trastuzumab/Abraxane for HER2-positive MBC
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	To evaluate the efficacy and safety of trastuzumab/Abraxane combination 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	Progression-free survival
Key secondary outcomes	Response rate 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	Abraxane: 260mg/m2, iv, day 1 Trastuzumab: 4mg/kg(loading dose) and then 2mg/kg, iv, day 1, 8, 15 or 8mg/kg(loading dose) and then 6mg/kg, iv, day 1, 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	75 years-old >=
Gender	Female
Key inclusion criteria	1. Histologically confirmed breast cancer with metastatic disease 2. Age are 20-75 years old 3. HER2 Overexpression (IHC3+) or HER2 gene amplification (FISH+) 4. No prior treatment with paclitaxel for metastatic breast cancer 5. with evaluable lesion 6. Performance status:0,1,2 7. LVEF>50% 8. Required baseline laboratory data(within 14 days of registration) WBC >4,000 /mm3 or Neut >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 creatin< 1.5mg/dL 9. Expected survival time: more than 3 months 10. Written informed consent
Key exclusion criteria	(1)With history of hypersensitivity reaction for trastuzumab, paclitaxel and albumin (2)With severe complication. (3)Pregnant or nursing women. (4)With widespread liver metastases or pulmonary lymphangitis with dyspnea (5) with active another cancer (6)with brain metastasis with symptom (7)with uncontrollable hypertension, angina pectoris, congestive heart failure, myocardial infection within 1 year, arrhythmia that need treat, valvular heart disease. (8)with pulmonary fibrosis or pneumonitis. (9)with dyspnea at rest (due to metastatic lung lesion and cardiovascular disease). (10)with pleural effusion, ascites, and pericardial effusion that need treat (11) Cases who physician judged improper to entry this trial
Target sample size	23

Research contact person
Name of lead principal investigator	Hirotaka Iwase
Organization	Kumamoto University, Graduate School of Medical Sciences
Division name	Department of Breast and Endocrine Surgery
Address	1-1-1 Honjo, Kumamoto, 862-8556, Japan
TEL	096-373-5521
Email

Public contact
Name of contact person	Yutaka Yamamoto
Organization	Kumamoto University, Graduate School of Medical Sciences
Division name	Department of Breast and Endocrine Surgery
Address	1-1-1 Honjo, Kumamoto, 862-8556, Japan
TEL	096-373-5521
Homepage URL
Email	breast@kumamoto-u.ac.jp

Sponsor
Institute	Kumamoto Breast Cancer Cooperative Group
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)

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	2011 Year 08 Month 15 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2011 Year 02 Month 07 Day
Anticipated trial start date	2011 Year 02 Month 07 Day
Last follow-up date	2016 Year 04 Month 30 Day
Date of closure to data entry	2016 Year 04 Month 30 Day
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	2011 Year 08 Month 12 Day
Last modified on	2018 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007074