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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041509
Receipt No. 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

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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
Email 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
Email mizunoy729@yokkaichihp01.jp

Sponsor
Institute Breast Surgery, Yokkaichi Municipal Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047388

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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