UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007180 |
|---|---|
| Receipt number | R000007139 |
| Scientific Title | A phase II neoadjuvant trial of sequential tri-weekly nanoparticle albumin-bound paclitaxel (Abraxane)/cyclophosphamide, with trastuzumab in HER2-positive patients, followed by 5-fluorouracil/epirubicine/cyclophosphamide (FEC) in operable breast cancer |
| Date of disclosure of the study information | 2012/02/01 |
| Last modified on | 2020/03/11 22:56:28 |
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Basic information
Public title
A phase II neoadjuvant trial of sequential tri-weekly nanoparticle albumin-bound paclitaxel (Abraxane)/cyclophosphamide, with trastuzumab in HER2-positive patients, followed by 5-fluorouracil/epirubicine/cyclophosphamide (FEC) in operable breast cancer
Acronym
TRI-ABC FEC trial
Scientific Title
A phase II neoadjuvant trial of sequential tri-weekly nanoparticle albumin-bound paclitaxel (Abraxane)/cyclophosphamide, with trastuzumab in HER2-positive patients, followed by 5-fluorouracil/epirubicine/cyclophosphamide (FEC) in operable breast cancer
Scientific Title:Acronym
TRI-ABC FEC trial
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 neoadjuvant sequential tri-weekly nanoparticle albumin-bound paclitaxel/cyclophosphamide (TRI-ABC), with trastuzumab in HER2-positive patients, followed by 5-fluorouracil/epirubicine/cyclophosphamide (FEC) in operable breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
pathological complete response (pCR)
Key secondary outcomes
pathological response
clinical response
safety
relapse-free survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
neoadjuvant sequential 4 cycle tri-weekly nanoparticle albumin-bound paclitaxel/Cyclophosphamide (TRI-ABC), with trastuzumab in HER2-positive patients, followed by 4 cycle 5-fluorouracil/epirubicine/cyclophosphamide (FEC)
TRI-ABC 4cycle
nab-paclitaxel 260mg/m2 iv day1 q3w
Cyclophosphamide 600mg/m2 iv day1 q3w
Patients who were HER2-positive receive trastuzumab with TRI-ABC, 8 mg/kg loading dose IV on
cycle 1 day 1 followed by doses of 6 mg/kg on day 1 of subsequent cycles
FEC 4cycle
5-Fluorouracil 500mg/m2 iv day 1 q3w
Epirubicin 100mg/m2 iv day 1 q3w
Cyclophosphamide 500mg/m2 iv day 1 q3w
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
Female
Histologically confirmed operable invasive breast carcinoma (T1c-3N0-2M0)
Age = 20-70 years
Evaluated ER and PgR status by IHC
Evaluated HER2 status by IHC and/or FISH
Adequate left ventricular ejection function (LVEF, >55%) at baseline (by ECHO or MUGA)
No prolongation of QTc time (QTc: <470msec)
Patient with measurable disease
Adequate organ function
ECOG Performance Status 0 or 1
Signed written informed consent
Key exclusion criteria
Known hypersensitivity to any of study drugs
History of receiving any endocrine therapy or chemotherapy for breast cancer within 5 years prior to registration
Concurrent, other malignancies
Concurrent bilateral breast cancer (except for contra-lateral non-invasive or lobular breast cancer)
Male
Concurrent, serious or uncontrolled infections
Inadequately controlled or serious history of cardiac disease
Inadequately controlled diabetes mellitus
Concurrent, gastrointestinal ulceration or bleeding
Current pregnancy and lactation, or possibility of pregnancy
Assessment by investigator that subject unable to comply with protocol
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Morihito |
| Middle name | |
| Last name | Okada |
Organization
Hiroshima university hospital
Division name
Department of surgical oncology
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-256-5869
morihito1217@gmail.com
Public contact
Name of contact person
| 1st name | Hideo |
| Middle name | |
| Last name | Shigematsu |
Organization
Hiroshima university hospital
Division name
Department of surgical oncology
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-256-5869
Homepage URL
shigematu1330@yahoo.co.jp
Sponsor or person
Institute
Dept of surgical oncology, Hiroshima university hospital
Institute
Department
Personal name
Funding Source
Organization
Dept of surgical oncology, Hiroshima university hospital
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
Dept of surgical oncology, Hiroshima university hospital
Address
1-2-3, Kasumi, Minami-ku, Hiroshima, Japan
Tel
082-257-5555
byo-keiei-tiken@office.hiroshima-u.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
| 2012 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/25454688
Number of participants that the trial has enrolled
54
Results
The treatment outcomes and
safety were evaluated in 54 patients who received at least 1 dose of chemotherapy. The overall pCR rate of 37% was achieved. The pCR rates according to each subtype were 8% in hormone receptor (HR)-positive HER2-negative breast cancer, 56% in HR-positive HER2-positive breast cancer, 63% in HR-negative HER2-positive breast cancer, and 62% in triple-negative breast
cancer. Clinical response was observed in 49 patients (91%). The safety profile was acceptable.
Results date posted
| 2019 | Year | 08 | Month | 03 | Day |
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
| 2011 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2011 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 31 | Day |
Last modified on
| 2020 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007139
| Research Plan | |
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