UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005388 |
|---|---|
| Receipt number | R000006397 |
| Scientific Title | Randomized Phase II trial of Neoadjuvant weekly Nab-paclitaxel followed by FEC compared with Docetaxel followed by FEC for early breast cancer |
| Date of disclosure of the study information | 2011/06/01 |
| Last modified on | 2021/04/27 15:22:28 |
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Basic information
Public title
Randomized Phase II trial of Neoadjuvant weekly Nab-paclitaxel followed by FEC compared with Docetaxel followed by FEC for early breast cancer
Acronym
ABI-007 Followed by FEC Neoadjuvant Chemotherapy for Breast Cancer (Randomized Phase II Trial)
Scientific Title
Randomized Phase II trial of Neoadjuvant weekly Nab-paclitaxel followed by FEC compared with Docetaxel followed by FEC for early breast cancer
Scientific Title:Acronym
ABI-007 Followed by FEC Neoadjuvant Chemotherapy for Breast Cancer (Randomized Phase II Trial)
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 early breast cancer.
Primary endpoint is to evaluate the pathological CR rate.
Secondary endpoint is to evaluate the Clinical response rate, pathological response rate, breast conserving rate, and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Primary endpoint is to evaluate the pathological CR rate.
Key secondary outcomes
Secondary endpoint is to evaluate the Clinical response rate, pathological response rate, breast conserving rate, and safety.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After 4 course of Docetaxel and FEC, surgical resection is carried out.
Docetaxel
Docetaxel 75 mg/m2 is administered intravenously at day 1. One course is consisted by 3 weeks and repeated to 4 courses.
FEC
After administrated 4 courses of Docetaxel, FEC(5-FU 500mg/m2, Epi-ADM 100mg/m2 and CPA 500mg/m2 are administered at day1) is carried out. One course is consisted by 3 weeks and repeated to 4 courses.
Interventions/Control_2
After 4 course of Weekly Nab-paclitaxel and FEC, surgical resection is carried out.
Weekly Nab-paclitaxel
Weekly Nab-paclitaxel 100 mg/m2 is administered intravenously at day 1, 8, 15. One course is consisted by 4 weeks and repeated to 4 courses.
FEC
After administrated 4 courses of Docetaxel, FEC(5-FU 500mg/m2, Epi-ADM 100mg/m2 and CPA 500mg/m2 are administered at day1) is carried out. One course is consisted by 3 weeks and repeated to 4 courses.
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) expected to radical cure by operation and neoadjuvant chemotherapy
4) has measurable region
5) Age more than 20 years old
6) no prior surgery, radiation, chemotherapy and endcrinethrapy
7) Required baseline laboratory parameters (within 14 days before registration):
Hb more than 9.0g/dl
WBC more than 3500 /mm3 and less than 12,000 /mm3
Neu more than 2000 / mm3
Plt more than 100,000/mm3
T-Bil less than 2 times ULM
AST less than 100 IU/L
ALT less than 100 IU/L
Cre less than 1.5 mg/dL
8) ECOG performance status is 0 to 2
9) Signed informed consent of the patient for the registration.
Key exclusion criteria
1) History of sever hypersensitivity
2) Her 2 overexpression (3+ by IHC stain or 2+ and FISH positive)
3) Active other malignancies
4) Severe complications (infection, diarrhea, intestine on the paralyzed, and ileus which affect to treatment, uncontrolled diabetes mellitus, uncontrolled angina, heart infarction
within 6 months, heart failure interstitial pneumonia or pulmonary fibrosis, cerebrovascular accident etc.)
5) has brain metastasis with symptoms
6) has psychological illness which became a problem in practice
7) received transfusion within 2 weeks because of bleeding in gastrointestinal tract
8) sever bone suppression, renal dysfunction, and liver dysfunction
9) sever pleural effusion or ascites fluid
10) water diarrhea at registration
11) has infection or fever which suspected of infection
12) history of hypersensitivity to Nab-paclitaxel, paclitaxel or albumin
13) pregnant or possibility of pregnant
14) history of sever hypersensitivity to docetaxel or polysorbate-containing product
15) Patients judged inappropriate by physicians
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Seigo |
| Middle name | |
| Last name | Nakamura |
Organization
Showa University
Division name
Department of Breast Surgical Oncology
Zip code
142-8666
Address
1-5-8, hatanodai, shinagawaku, Tokyo, japan
TEL
03-3784-8727
breastc@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Kuwayama |
Organization
Showa University
Division name
Department of Breast Surgical Oncology
Zip code
142-8666
Address
1-5-8, hatanodai, shinagawaku, Tokyo, japan
TEL
03-3784-85-8511
Homepage URL
breastc@med.showa-u.ac.jp
Sponsor or person
Institute
Department of Breast Surgical Oncology, Showa University
Institute
Department
Personal name
Funding Source
Organization
Japan Society of Clinical Oncology (Clinical Research Program Grant)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bio-Ethical Committee,Showa University
Address
1-5-8, hatanodai, shinagawaku, Tokyo, japan
Tel
03-3784-8000
mkyoumu@ofc.showa-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
昭和大学病院（東京都）
昭和大学藤が丘病院（東京都）
聖路加国際病院（東京都）
東京医科歯科大学（東京）
東京共済病院（東京）
虎ノ門病院（東京）
聖マリアンナ医科大学（神奈川）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 06 | Day |
Last modified on
| 2021 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006397
