UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Phase II study of Neoadjuvant chemotherapy in Docetaxel and Cyclophosphamide(TC therapy) with Operable HER2 Negative breast cancer
Title of the study (Brief title)	A Phase II study of Neoadjuvant chemotherapy in Docetaxel and Cyclophosphamide(TC therapy) with Operable HER2 Negative 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 Tri-weekly Docetaxel and Cyclophosphamide (TC therapy) of 4 cycles in patients with HER2 negative operable breast cancer.
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	(1) Safety, adverse events (2) Overall response rate (3) Breast conserving rate

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 TC therapy(Docetaxel and Cyclophosphamide). Operation is to be performed after chemotherapy. nab-Paclitaxel(260mg/m2) intravenously on day 1 of each 3-weeks. FEC(5-Fluorouracil 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/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	70 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 (T1c-3 N0-1 M0) and tumor size is 7 cm or smaller. 2)Age between 20 to 70 years old 3)ECOG performance status (PS): 0-1 4)No previous treatments for breast cancer such as chemotherapy, hormone therapy, molecular target therapy, radiotherapy and immunotherapy. 5)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 h)Baseline left ventricular ejection fraction (LVEF) is >=60% measured by echocardiography or MUGA scan. 6)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	Tetsuya Taguchi
Organization	Kyoto Prefectural University of Medicine
Division name	Endocrine & Breast Surgery
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	Katsuhiko Nakatsukasa
Organization	Kyoto Prefectural University of Medicine
Division name	Endocrine & Breast Surgery
Address	Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 465
TEL	075-251-5534
Homepage URL
Email	kacchan@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Kyoto Prefectural University of Medicine
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	2014 Year 02 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 07 Month 01 Day
Anticipated trial start date	2012 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 02 Month 25 Day
Last modified on	2018 Year 09 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015429