UMIN-CTR Clinical Trial

Basic information
Public title	A phase II neoadjuvant trial of sequential nab-paclitaxel followed by dose dense epirubicine/cyclophosphamide (ddEC) in operable breast cancer
Acronym	A phase II neoadjuvant trial of sequential nab-paclitaxel followed by ddEC in operable breast cancer
Scientific Title	A phase II neoadjuvant trial of sequential nab-paclitaxel followed by dose dense epirubicine/cyclophosphamide (ddEC) in operable breast cancer
Scientific Title:Acronym	A phase II neoadjuvant trial of sequential nab-paclitaxel followed by ddEC in operable breast cancer
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of neoadjuvant chemotherapy of sequential nab-paclitaxel followed by dose dense epirubicine/cyclophosphamide (ddEC) in operable breast cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Pathological complete response (pCR) in breast and axillary lymph node
Key secondary outcomes	Adverse events with nab-paclitaxel and ddEC therapy

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	neoadjuvant sequential 4cycle nab-paclitaxel tri-weekly, with trastuzumab, pertuzumab in HER2-positive patients, followed by 4 cycle dose dense epirubicine/cyclophosphamide (ddEC) tri-weekly nab-paclitaxel 4cycle nab-paclitaxel 260mg/m2, day1, q3w HER2-positive disease, trastuzumab 8mg/kg, 6mg/kg and pertuzumab 840mg, 420mg on day1 of subsequent cycles with nab-paclitaxel ddEC 4cycle Epirubicin 90mg/m2, Cyclophosphamide 600mg/m2, day 1, q2w
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 operable breast c ancer 2)Clinical stage 1, 2, 3 3)Operable breast cancer in neoadjuvant setting 4)Over 20 year-old, under 75 year-old female 5)Previously untreated by operation, radiotherapy, chemotherapy, endocrine therapy 6)Exhibited adequate organ function 7)Performance status(PS) 0-1 8)Signed written informed consent
Key exclusion criteria	1)Known hypersensitivity to human serum alb umin 2)Concurrent, serious or uncontrolled infect ions 3)Inadequately controlled or serious history of cardiac disease 4)Confirmed symptomatic brain metastasis 5)Current pregnancy and lactation, or possib ility of pregnancy 6)Known drug allergy to any of study drugs 7)Assessment by investigator that subject un able to comply with protocol
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Yutaka Middle name Last name Mizuno
Organization	Yokkaichi Municipal Hospital
Division name	Breast Surgery
Zip code	510-8567
Address	2-2-37 Shibata Yokkaichi-city Mie
TEL	059-354-1111
Email	mizunoy729@yokkaichihp01.jp

Public contact
Name of contact person	1st name Yutaka Middle name Last name Mizuno
Organization	Yokkaichi Municipal Hospital
Division name	Breast Surgery
Zip code	510-8567
Address	2-2-37 Shibata Yokkaichi-city Mie
TEL	059-354-1111
Homepage URL
Email	mizunoy729@yokkaichihp01.jp

Sponsor
Institute	Breast Surgery, Yokkaichi Municipal Hospital
Institute
Department

Funding Source
Organization	Breast Surgery, Yokkaichi Municipal Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board, Yokkaichi Municipal Hospital
Address	2-2-37 Shibata Yokkaichi-city Mie
Tel	059-354-1111
Email	chiken@yokkaichihp01.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	市立四日市病院（三重県）

Other administrative information
Date of disclosure of the study information	2020 Year 09 Month 01 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	2020 Year 04 Month 16 Day
Date of IRB	2020 Year 07 Month 16 Day
Anticipated trial start date	2020 Year 07 Month 17 Day
Last follow-up date	2025 Year 12 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	2020 Year 08 Month 21 Day
Last modified on	2020 Year 08 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047388