UMIN-CTR Clinical Trial

Basic information
Public title	Phase 2 study of dose-dense nab-paclitaxel followed by EC as neoadjuvant chemotherapy for HER2-negative breast cancer
Acronym	Phase 2 study of dose-dense nab-paclitaxel followed by EC as neoadjuvant chemotherapy for HER2-negative breast cancer
Scientific Title	Phase 2 study of dose-dense nab-paclitaxel followed by EC as neoadjuvant chemotherapy for HER2-negative breast cancer
Scientific Title:Acronym	Phase 2 study of dose-dense nab-paclitaxel followed by EC as neoadjuvant chemotherapy for HER2-negative breast cancer
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of dose-dense Nab-PTX followed by EC as neoadjuvant chemotherapy for HER2-negative primary breast cancer. To evaluate the effect of cryotherapy and compression therapy using stockings, and prophylactic medication including goshajinkigan, mecobalamin and lafutidine for prevention of nab-PTX- induced peripheral neuropathy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Pathological complete response rate
Key secondary outcomes	Clinical response rate, disease-free survival, adverse events, the evaluation of peripheral neuropathy by Patient Neurotoxicity Questionnaire (PNQ), the evaluation of QOL by FACT-Taxane

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 Device,equipment
Interventions/Control_1	Neoadjuvant chemotherapy with 4 cycles of dose-dense (every 2 week) Nab-PTX (260mg/m2) followed by 4 cycles of dose-dense (every 2 week) EC therapy (epirubicin 90 mg/m2 and CPA 600 mg/m2). Pegfilgrastim (3.6mg) will be administered on day2 or 3 of every cycle. Patients will receive cryotherapy using ice and wear elastic stockings during nab-PTX administration, and will receive prophylactic medication over the course of treatment; including goshajinkigan (7.5 g/day), mecobalamin (1,500 ug/day) and lafutidine (20 mg/day).
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) Female breast cancer histologically diagnosed HER2-negative primary invasive breast cancer 2) Stage 1-3 3) No previous treatment for breast cancer 4) 20 years old or older 5) Performance Status (PS) 0-1 6) Results from a laboratory test meet the following: Leukocyte count is >=3000/mm3 or Neutrophil count is >=2000/mm3 Platelet >=100 000/mm3 Hemoglobin >=9.0g/dL AST and ALT <=x 1.5 of upper limit of normal (ULN) Total bilirubin <=x 1.5 of ULN Serum creatinine <=x 1.5 of ULN 7) No poorly controlled complication 8) Signed written informed consent
Key exclusion criteria	1) Women who are pregnant or lactating 2) Multiple primary cancer 3) HER2-positive breast cancer 4) Poorly controlled complication (interstitial pneumonia, severe diabetes, heart failure, renal insufficiency, hepatic insufficiency) 5) Active infection 6) Serious peripheral neuropathy (>=CTCAE grade2) 7) Ineligible based on decision of an investigator
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Hiromitsu Middle name Last name Jinno
Organization	Teikyo University School of Medicine
Division name	Department of Surgery
Zip code	173-8606
Address	2-11-1 Kaga, Itabashi-ku, Tokyo, Japan
TEL	+81-3-3964-1211
Email	jinno@med.teikyo-u.ac.jp

Public contact
Name of contact person	1st name Hiromitsu Middle name Last name Jinno
Organization	Teikyo University School of Medicine
Division name	Department of Surgery
Zip code	173-8606
Address	2-11-1 Kaga, Itabashi-ku, Tokyo, Japan
TEL	+81-3-3964-1211
Homepage URL
Email	jinno@med.teikyo-u.ac.jp

Sponsor
Institute	Teikyo University School of Medicine
Institute
Department

Funding Source
Organization	Teikyo University School of Medicine
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	Teikyo university institutional review board
Address	2-11-1 Kaga, Itabashi-ku, Tokyo, Japan
Tel	03-3964-7256
Email	turb-office@teikyo-u.ac.jp

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	2017 Year 02 Month 20 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	Open public recruiting
Date of protocol fixation	2017 Year 01 Month 12 Day
Date of IRB
Anticipated trial start date	2017 Year 02 Month 20 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	2017 Year 02 Month 15 Day
Last modified on	2020 Year 02 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030036