UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000007180
Receipt No. 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 (Ver. 11)

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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
Email 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
Email shigematu1330@yahoo.co.jp

Sponsor
Institute Dept of surgical oncology, Hiroshima university hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007139