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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013261
Receipt No. R000015429
Scientific Title A Phase II study of Neoadjuvant chemotherapy in Docetaxel and Cyclophosphamide(TC therapy) with Operable HER2 Negative breast cancer
Date of disclosure of the study information 2014/02/28
Last modified on 2018/09/10

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Basic information
Public title A Phase II study of Neoadjuvant chemotherapy in Docetaxel and Cyclophosphamide(TC therapy) with Operable HER2 Negative breast cancer
Acronym A Phase II study of Neoadjuvant chemotherapy in Docetaxel and Cyclophosphamide(TC therapy) with Operable HER2 Negative breast cancer
Scientific Title A Phase II study of Neoadjuvant chemotherapy in Docetaxel and Cyclophosphamide(TC therapy) with Operable HER2 Negative breast cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Tetsuya Taguchi
Organization Kyoto Prefectural University of Medicine
Division name Endocrine & Breast Surgery
Zip code
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
Middle name
Last name Katsuhiko Nakatsukasa
Organization Kyoto Prefectural University of Medicine
Division name Endocrine & Breast Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

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
2012 Year 07 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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