UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005704 |
|---|---|
| Receipt number | 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 11:06:29 |
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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 – 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
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
koitsuga@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006745
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