UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041509 |
|---|---|
| Receipt number | R000047388 |
| Scientific Title | A phase II neoadjuvant trial of sequential nab-paclitaxel followed by dose dense epirubicine/cyclophosphamide (ddEC) in operable breast cancer |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2020/08/21 19:06:57 |
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Basic information
Public title
A phase II neoadjuvant trial of sequential nab-paclitaxel followed by dose dense epirubicine/cyclophosphamide (ddEC) in operable breast cancer
Acronym
A phase II neoadjuvant trial of sequential nab-paclitaxel followed by ddEC in operable breast cancer
Scientific Title
A phase II neoadjuvant trial of sequential nab-paclitaxel followed by dose dense epirubicine/cyclophosphamide (ddEC) in operable breast cancer
Scientific Title:Acronym
A phase II neoadjuvant trial of sequential nab-paclitaxel followed by ddEC in operable breast cancer
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 chemotherapy of sequential nab-paclitaxel followed by dose dense epirubicine/cyclophosphamide (ddEC) in operable breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Pathological complete response (pCR) in breast and axillary lymph node
Key secondary outcomes
Adverse events with nab-paclitaxel and ddEC therapy
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 4cycle nab-paclitaxel tri-weekly, with trastuzumab, pertuzumab in HER2-positive patients, followed by 4 cycle dose dense epirubicine/cyclophosphamide (ddEC) tri-weekly
nab-paclitaxel 4cycle
nab-paclitaxel 260mg/m2, day1, q3w
HER2-positive disease, trastuzumab 8mg/kg,
6mg/kg and pertuzumab 840mg, 420mg on day1 of subsequent cycles with nab-paclitaxel
ddEC 4cycle
Epirubicin 90mg/m2, Cyclophosphamide 600mg/m2, day 1, q2w
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
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Histologically confirmed operable breast c ancer
2)Clinical stage 1, 2, 3
3)Operable breast cancer in neoadjuvant setting
4)Over 20 year-old, under 75 year-old female
5)Previously untreated by operation, radiotherapy, chemotherapy, endocrine therapy
6)Exhibited adequate organ function
7)Performance status(PS) 0-1
8)Signed written informed consent
Key exclusion criteria
1)Known hypersensitivity to human serum alb umin
2)Concurrent, serious or uncontrolled infect ions
3)Inadequately controlled or serious history of cardiac disease
4)Confirmed symptomatic brain metastasis
5)Current pregnancy and lactation, or possib ility of pregnancy
6)Known drug allergy to any of study drugs
7)Assessment by investigator that subject un able to comply with protocol
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Mizuno |
Organization
Yokkaichi Municipal Hospital
Division name
Breast Surgery
Zip code
510-8567
Address
2-2-37 Shibata Yokkaichi-city Mie
TEL
059-354-1111
mizunoy729@yokkaichihp01.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Mizuno |
Organization
Yokkaichi Municipal Hospital
Division name
Breast Surgery
Zip code
510-8567
Address
2-2-37 Shibata Yokkaichi-city Mie
TEL
059-354-1111
Homepage URL
mizunoy729@yokkaichihp01.jp
Sponsor or person
Institute
Breast Surgery, Yokkaichi Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Breast Surgery, Yokkaichi Municipal Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Yokkaichi Municipal Hospital
Address
2-2-37 Shibata Yokkaichi-city Mie
Tel
059-354-1111
chiken@yokkaichihp01.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
市立四日市病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2020 | Year | 08 | Month | 21 | Day |
Last modified on
| 2020 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047388
