UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013261 |
|---|---|
| Receipt number | 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 14:21:02 |
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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
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
kacchan@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015429
