UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of neoadjuvant nab-paclitaxel and trastuzumab for ER negative and HER2 positive breast cancer
Acronym	Neoadjuvant nab-PTX and trastuzumab for ER negative and HER2 positive breast cancer
Scientific Title	Phase II study of neoadjuvant nab-paclitaxel and trastuzumab for ER negative and HER2 positive breast cancer
Scientific Title:Acronym	Neoadjuvant nab-PTX and trastuzumab for ER negative and HER2 positive breast cancer
Region	Japan

Condition
Condition	ER negative and HER2 positive breast cancer
Classification by specialty	Hematology and clinical oncology Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the efficacy and safety of nab-paclitavel (PTX) and trastuzumab for ER negative and HER2 positive operable (tumor size of 3cm or less and N0) breast cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Pathologic complete response rate (Up to 12 weeks after the protocol therapy)
Key secondary outcomes	Disease free survival Objective response rate Pathologocal response rate Rate of breast conserving surgery Safety profile

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	Four cycles of nab-PTX 260 mg/m2 with trastuzumab 6 mg/kg (8 mg/kg as the loading dose). One year of adjuvant trastuzumab will be administrated. Anthracycline regimens may be administered by physician's choice for the case expected to have a high risk of recurrence based on the pathological findings of surgical specimen. Adjuvant endocrine therapy may be administrated for the case with weakly hormone-sensitive (1-9% of positive cells) tumor.
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	70 years-old >=
Gender	Female
Key inclusion criteria	1. Histologically confirmed invasive breast cancer 2. Tumor size of 3cm or less and N0 3. Hormone receptors have been identified as negative 4. HER2 positive confirmed by IHC 3+ or FISH+ 5. LVEF > 50% by echocardiogram or MUGA 6. Adequate EKG 7. No prior treatment for breast cancer 8. PS 0-1 9. Required baseline laboratory data WBC > 4,000/mm3 and Neut > 2,000/mm3 PLT > 100,000/mm3 Hb > 9.0g/dl AST and ALT < ULNx2.5 T-Bil < 1.5mg/dl Serum creatinin < 1.5mg/dl 10. Written informed consent
Key exclusion criteria	1. With history of hypersensitivity reaction for important drug in this study 2. With history of invasive breast cancer 3. Bilateral invasive breast cancer 4. Patients with medical conditions that renders them intolerant to primary chemotherapy and related treatment, including infection, diarrhea, intestinal paralysis, severe Diabetes Mellitus 5. Positive for HBs antigen or HCV antibody 6. With history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction, poorly controlled hypertension 7. With severe edema 8. With severe peripheral neuropathy 9. With severe psychiatric disorder 10. Pregnant or nursing women 11. The case that is judged to be unsuitable for this study by physician
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name Mitsuhiko Middle name Last name Iwamoto
Organization	Osaka Medical College Hospital
Division name	Breast and endocrine surgery
Zip code	5698686
Address	2-7 Daigaku-machi, Takatsuki-city, Osaka 569-8686, Japan
TEL	0726831221
Email	sur067@osaka-med.ac.jp

Public contact
1st name of contact person	1st name Satoru Middle name Last name Tanaka
Organization	Osakaminami Medical Center
Division name	Breast surgery
Zip code	5868521
Address	2-1 Kidohigashicho, Kawachinagano, Osaka 586-8521, Japan
TEL	0721-53-5761
Homepage URL
Email	sur112@osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College
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	Review board of Osaka Medical College
Address	2-7 Daigaku-machi, Takatsuki-city, Osaka 569-8686, Japan
Tel	0726831221
Email	rinri@osaka-med.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT02598310
Org. issuing International ID_1	ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 04 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	18
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	Main results already published
Date of protocol fixation	2015 Year 08 Month 27 Day
Date of IRB	2015 Year 11 Month 02 Day
Anticipated trial start date	2015 Year 11 Month 04 Day
Last follow-up date	2019 Year 04 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 11 Month 03 Day
Last modified on	2019 Year 05 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022429