UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009035
Receipt number R000010602
Scientific Title Phase II study of neoadjuvant chemotherapy with nab-Paclitaxel followed by EC for resectable primary breast cancer
Date of disclosure of the study information 2012/10/03
Last modified on 2020/04/09 09:14:11

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Basic information

Public title

Phase II study of neoadjuvant chemotherapy with nab-Paclitaxel followed by EC for resectable primary breast cancer

Acronym

PerSeUS-BC01

Scientific Title

Phase II study of neoadjuvant chemotherapy with nab-Paclitaxel followed by EC for resectable primary breast cancer

Scientific Title:Acronym

PerSeUS-BC01

Region

Japan


Condition

Condition

Resectable primary breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Evaluation of the effectiveness and the safety of the following protocol; Phase II study of neoadjuvant chemotherapy with nab-Paclitaxel followed by EC for resectable primary 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 rate
pCR rate

Key secondary outcomes

Response rate
Histological therapeutic effect
Safety
Breast conserving rate
QOL


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

After 4 cycles of nab-Paclitaxel followed by 4 cycles of EC, surgical resection is carried out.

nab-Paclitaxel
(HER2 negative)
nab-Paclitaxel 260mg/m2 iv day1 q3w
(HER2 positive)
nab-Paclitaxel 260mg/m2 iv day1 q3w
Trastuzumab 6 mg/kg iv day1 q3w
(8 mg/kg in only first course)

EC
Epirubicin 90mg/m2 iv day 1 q3w
Cyclophosphamide 600mg/m2 iv day 1 q3w

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

70 years-old >

Gender

Female

Key inclusion criteria

1) Histologically confirmed breast cancer
2)ER positive, HER2 negative and Ki-67 >=15 or Nuclear grade 3
ER positive and HER2 positive
ER negative and HER2 positive
Triple negative
3)Clinical stage I-IIIB
4)Radical cure by operation and neoadjuvant chemotherapy
5) With measurable lesions
6) Age between 20 and 69 years at registration
7) Performance status of 0 or 1
8) With no prior surgery, radiotherapy, chemotherapy and endocrine therapy for breast cancer
9) Normal LVEF (LVEF> 50%) measured by the MUGA scan or the echocardiogram (HER2 positive)
10) Adequate organ function shown in physical examinations within 14 days before the registration
White blood cell count =>3000/mm3
Neutrophil count =>1500/mm3
Platelet count =>100000/mm3
Hemoglobin =>9.0g/dL
AST<= 2.5 x ULN
ALT <= 2.5 x ULN
Total bilirubin <=1.5mg/dL
Creatinine <=1.5mg/dL
Adequate cardiac function



11) Patient who undertook sentinel lymph node biopsy, if any
12)Written informed consent

Key exclusion criteria

1) Inflammatory, bilateral or mucinous breast cancer
2) Synchronous cancer, or metachronous cancer with less than 5 years of disease-free interval
3) Severe complication(s), e.g., congestive cardiac failure, coronary failure, cardiac infarction, angina pectoris, arrhythmia, cerebrovascular disease, active gastrointestinal tract ulcer, diabetes, renal failure, hepatic failure, active hepatitis or hepatic cirrhosis.
4) Active infection
5) Interstitial pneumonitis or pulmonary fibrosis identified by chest radiography or chest CT
6) Positive for HBs antigen or HCV antibody
7) Uncontrollable peripheral neuropathy
8) History of drug allergy
9) Pregnant / nursing
10) Severe mental disorders
11) Disqualified by investigator

Target sample size

36


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhiro Yoshida

Organization

Gifu University graduate school of medicine

Division name

Department of surgical oncology

Zip code


Address

1-1 Yanagido, Gifu city

TEL

058-230-6000

Email

kyoshida@gofi-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Manabu Futamura

Organization

Gifu University graduate school of medicine

Division name

Breast and molecular oncology

Zip code


Address

1-1 Yanagido, Gifu city

TEL

058-230-6000

Homepage URL


Email

mfutamur@gifu-u.ac.jp


Sponsor or person

Institute

PerSeUS:Perpetual Study estimated-by United Sections in Gifu

Institute

Department

Personal name



Funding Source

Organization

Gifu Univ
Dept of Surgical Oncology

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



Other administrative information

Date of disclosure of the study information

2012 Year 10 Month 03 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

Completed

Date of protocol fixation

2012 Year 05 Month 17 Day

Date of IRB

2013 Year 02 Month 26 Day

Anticipated trial start date

2012 Year 05 Month 17 Day

Last follow-up date

2014 Year 09 Month 30 Day

Date of closure to data entry

2016 Year 04 Month 20 Day

Date trial data considered complete

2016 Year 12 Month 21 Day

Date analysis concluded

2016 Year 12 Month 26 Day


Other

Other related information



Management information

Registered date

2012 Year 10 Month 03 Day

Last modified on

2020 Year 04 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010602


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name