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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005704
Receipt No. R000006745
Scientific Title Feasibility study of Nab-paclitaxel followed by FEC as Neoadjuvant Chemotherapy for Primary Breast Cancer
Date of disclosure of the study information 2011/06/01
Last modified on 2018/08/03

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Basic information
Public title Feasibility study of Nab-paclitaxel followed by FEC as Neoadjuvant Chemotherapy for Primary Breast Cancer
Acronym Feasibility study of Nab-paclitaxel followed by FEC as Neoadjuvant Chemotherapy for Primary Breast Cancer
Scientific Title Feasibility study of Nab-paclitaxel followed by FEC as Neoadjuvant Chemotherapy for Primary Breast Cancer
Scientific Title:Acronym Feasibility study of Nab-paclitaxel followed by FEC as Neoadjuvant Chemotherapy for 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 weekly Nab-paclitaxel followed by FEC as neoadjuvant chemotherapy for primary breast cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Feasibility
Key secondary outcomes adverse event
pathological complete response rate
clinical response rate
pathological response rate
rate of breast-conserving surgery

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 4 cycles of weekly nab-paclitaxel followed by 4 cycles of FEC

[weekly nab-paclitaxel]
nab-paclitaxel 150 mg/m2 administered weekly on days 1, 8, and, 15 of each 4-week cycle

[FEC]
5-FU 500 mg/m2, Epi-ADM 100 mg/m2 and CPA 500 mg/m2 administered intravenously on day 1 of each 3-week cycle
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

Not applicable
Gender Female
Key inclusion criteria 1) Histologically confirmed primary breast cancer
2) Clinical stage T1c-3 N0/M0 or T1-3 N1/M0
3) At least one measurable lesion
4) Age >= 20 years
5) No prior surgery, radiation, chemotherapy and endocrine therapy
6) Required baseline laboratory parameters (within 14 days before registration)
Hb: >= 8.0 g/dL
WBC: >= 3000 /mm3 and <= 12,000 /mm3
Neu: >= 2,000 / mm3
Plt: >= 75,000 / mm3
T-Bil: <= 2 times ULM
AST: <= 2 times ULN
ALT: <= 2 times ULN
Cre: <= ULN
7) ECOG performance status of 0 &#8211; 2
8) written informed consent
Key exclusion criteria 1) allergy of the medication
2) IHC 3+, IHC 2+ and FISH +
3) Active double cancer
4) Severe complications
5) Symptomatic brain metastasis
6) Severe mental disorder
7) receive blood transfusions within 2 weeks
8) Sever bone marrow suppression, renal dysfunction, liver dysfunction
9) Sever body cavity fluid
10) Patients with diarrhea
11) Active infection or potentiality infection
12) allergy of the nab-paclitaxel, paclitaxel or albumin
13) During pregnancy or lactation
14) Judged by the investigator to be unfit to be enrolled into the study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichiro Tsugawa, M.D.
Organization St. Marianna University School of Medicine
Division name Division of Breast and Endocrine Surgery
Zip code
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki-city, Kanagawa, Japan
TEL 044-977-8111
Email koitsuga@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichiro Tsugawa, M.D.
Organization St. Marianna University School of Medicine
Division name Division of Breast and Endocrine Surgery
Zip code
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki-city, Kanagawa, Japan
TEL 044-977-8111
Homepage URL
Email koitsuga@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
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)

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 聖マリアンナ医科大学(神奈川県)

Other administrative information
Date of disclosure of the study information
2011 Year 06 Month 01 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
Thirty-seven patients were included (age: 35~67-years, mean 51). Twenty-nine patients completed the treatment as per protocol (the completion rate; 78%). Two patients stopped by progressive disease, five patients stopped by severe fatigue, and one patient stopped by liver dysfunction. The average age of patients with completion was 50-years, which is younger than the one of patients with un-completion, 61-years. The rate of dose-reduction according to protocol was 38% (14 patients) in the nab-paclitaxel treatment, and 3% (one patient) in the FEC treatment. The incidence of grade 3/4 toxicity: neutropenia (24%), neuropathy (41%), fatigue (30%), and musculoskeletal pain (14%) were observed. The efficacy was evaluated in 34 patients, excluded the over-staged patients (cStage IIIB and IIIC). The pCR rate was 27% in 34 patients. pCR was observed in 2 of the 22 ER-positive patients (9%) and in 7 of the 12 ER-negative patients (58%). Five (15%) and 23 (68%) patients had complete and partial responses by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Twenty-four (71%) patients received breast-conserving surgery.
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
2011 Year 05 Month 17 Day
Date of IRB
Anticipated trial start date
2011 Year 06 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
2012 Year 12 Month 01 Day
Date trial data considered complete
2012 Year 12 Month 01 Day
Date analysis concluded
2012 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 06 Month 01 Day
Last modified on
2018 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006745

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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