UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observational study of Nab-paclitaxel followed by Anthracycline based regimen as preoperative chemotherapy for ER-negative resectable primary breast cancer
Title of the study (Brief title)	Observational study of Nab-paclitaxel followed by Anthracycline based regimen as preoperative chemotherapy for ER-negative resectable primary breast cancer
Region	Japan

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

Objectives
Narrative objectives1	evaluate the efficacy and safety of the preoperative chemotherapy with nab-paclitaxel (with or without Trastuzumab) followed by Anthracycline based regimen for the ER-negative resectable primary breast cancer. To evaluate the relevance of expression of the molecular marker (Caveolin-1 (Cav1), SPARC) and therapeutic effects
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pathological complete response rate
Key secondary outcomes

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	Preoperative chemotherapy with nab-paclitaxel(with or without Trastuzumab) therapy 4 courses followed by Anthracycline based regimen four courses, to perform the surgery
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 breast cancer histologically diagnosed primary invasive breast cancer 2)stage2-3A 3) radical resection can be expected by preoperative chemotherapy and surgery 4)patients with measurable lesions 5)diagnosed ER-negative 6)20 years old or older, 75 years old or younger 7)performance Status (PS) 0-1 8)no previous treatment, surgery, radiation therapy, chemotherapy, endocrine therapy 9) LVEF values is determined to be proper (> 50%) by echocardiography or MUGA 10)major organ function is sufficiently held in the clinical examination of the registration within 14 days prior 11)consent is obtained from the patient himself in writing for the test participation
Key exclusion criteria	1)patients with previous treatment history of nab-paclitaxel 2)active double cancer (synchronous double cancer and metachronous double cancer disease-free period is within 5 years) 3)serious complications (congestiveheart failure, coronary insufficiency, heart disease such as a myocardial infarction and angina pectoris and Arrhythmia requiring treatment, history of cerebrovascular disease, gastrointestinal ulcer bleeding or requiring treatment, control bad diabetes, renal failure, active hepatitis and cirrhosis, liver failure, etc.) 4)has a fever, suspected infection 5)pleural effusion requiring treatment, pericardial effusion example 6)a clear interstitial pneumonia or pulmonary fibrosis in the chest X photos and chest CT 7)a history of drug hypersensitivity 8)a history of severe hypersensitivity for the components of the therapeutic agent (nab-paclitaxel) 9) a possibility of pregnancy and pregnancy, or breast-feeding 10)history of serious mental illness or are under treatment, patients judged that the participation in examination is difficult 11)HBs antigen-positive 12)Other cases of the physician has determined to be inappropriate as a target
Target sample size	40

Research contact person
Name of lead principal investigator	Kazuhiko Yamagami
Organization	SHINKO HOSPITAL
Division name	Department of Breast Surgery
Address	1-4-47, WAKINOHAMACHO, CHUO-KU, KOBE, 651-0072
TEL	078-261-6711
Email	kazu.yama.-0825@shinkohp.or.jp

Public contact
Name of contact person	Kazuhiko Yamagami
Organization	SHINKO HOSPITAL
Division name	Department of Breast Surgery
Address	1-4-47, WAKINOHAMACHO, CHUO-KU, KOBE, 651-0072
TEL	078-261-6711
Homepage URL
Email	kazu.yama.-0825@shinkohp.or.jp

Sponsor
Institute	SHINKO HOSPITAL
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)

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 02 Month 12 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 06 Month 13 Day
Anticipated trial start date	2012 Year 06 Month 13 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 12 Day
Last modified on	2016 Year 10 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024236