UMIN-CTR Clinical Trial

Basic information
Public title	Phase2 study of dose dense EC followed Nab-PTXas neoadjuvant chemotherapy for HER2-negative primary breast cancer
Acronym	Phase2 study of dose dense EC followed Nab-PTXas neoadjuvant chemotherapy for HER2-negative primary breast cancer
Scientific Title	Phase2 study of dose dense EC followed Nab-PTXas neoadjuvant chemotherapy for HER2-negative primary breast cancer
Scientific Title:Acronym	Phase2 study of dose dense EC followed Nab-PTXas neoadjuvant chemotherapy for HER2-negative primary 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 preoperative administration of Dose dense biweekly Epirubicine and Cyclophosphamide (EC therapy) of 4 cycles followed by nab-PTX of 4 cycles in patients with HER2 negative operable breast cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	pathological complete response
Key secondary outcomes	response rate the rates of breast conserving surgery dosease free survival overall survival side effects

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	Administrate 4 cycles of dose dense EC therapy(Epirubicine and Cyclophosphamide) followed by 4 cycles of nab-PTX. Operation is to be performed after chemotherapy. EC(, Epirubicin 90mg/m2, Cyclophosphamide 600mg/m2) intravenously on day 1 of each 2-weeks nab-Paclitaxel(260mg/m2) intravenously on day 1 of each 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) Female primary breast cancer patients who are diagnosed as invasive breast cancer by needle biopsy or tissue biopsy. Resectable primary breast cancer (T2-4 any N M0) 2)luminal B(ER positive,Ki67index>=20%) or Triple negative(ER negative PgR negative HER2 negative) 3)Age between 20 to 75 years old 4)ECOG performance status (PS): 0-1 5)No previous treatments for breast cancer such as chemotherapy, hormone therapy, molecular target therapy, radiotherapy and immunotherapy. 6)Results from a laboratory test meet the following: a)Leukocyte count is >=3000/mm3 or b)Neutrophil count is >=2000/mm3 c)Hemoglobin >=9.0g/dL d)Platelet >=100 000/mm3 e)AST and ALT <=x 2.0 of upper limit of normal (ULN) f)Bilirubin (total bilirubin or direct bilirubin) <=1.5 of ULN g)Serum creatinine <=x 1.5 of ULN 7)Signed written informed consent
Key exclusion criteria	1)Poorly controlled complication (malignant hypertension, myocardial infarction , congestive heart failure, bleeding). 2)Multiple primary cancer 3)Synchronous bilateral breast cancer 4)Interstitial pneumonia and pulmonary fibrosis diagnosed by chest X-rays or CT scan. 5)Women who are pregnant, lactating or with childbearing potential 6)Hypersensitivity to any agents necessary in the planned treatment. 7)Serious peripheral neuropathy or serious edema 8)Pleural effusion or cardiac effusion which requires treatment 9)Complication which requires prior treatment with corticosteroid 10)Suspected infection 11)Ineligible based on decision of an investigator
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Tetsuya Middle name Tetsuya Taguchi Last name Taguchi
Organization	Kyoto Prefectural University of Medicine
Division name	Endocrine & Breast Surgery
Zip code	602-8566
Address	465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 465
TEL	075-251-5534
Email	ttaguchi@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name Ayana Middle name Ayana Sakuramachi Last name Sakuramachi
Organization	Kyoto Prefectural University of Medicine
Division name	Endocrine & Breast Surgery
Zip code	602-8566
Address	465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 465
TEL	075-251-5534
Homepage URL
Email	ayana-s@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Kyoto Prefectural University of Medicine Endocrine & Breast Surgery
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	Kyoto Prefectural University of Medicine Endocrine & Breast Surgery IRB
Address	465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 465
Tel	075-251-5337
Email	rinri@koto.kpu-m.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	2016 Year 04 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	Completed
Date of protocol fixation	2016 Year 04 Month 01 Day
Date of IRB	2016 Year 04 Month 19 Day
Anticipated trial start date	2016 Year 05 Month 01 Day
Last follow-up date	2021 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 01 Month 21 Day
Last modified on	2019 Year 07 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023875