UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022931
Receipt number R000026428
Scientific Title PhaseII study of Nab-paclitaxel followed by EC as neoadjuvant chemotherapy for the operable breast cancer
Date of disclosure of the study information 2016/07/01
Last modified on 2018/05/23 17:07:13

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Basic information

Public title

PhaseII study of Nab-paclitaxel followed by EC as neoadjuvant chemotherapy for the operable breast cancer

Acronym

PhaseII study of Nab-paclitaxel followed by EC as neoadjuvant chemotherapy for the operable breast cancer

Scientific Title

PhaseII study of Nab-paclitaxel followed by EC as neoadjuvant chemotherapy for the operable breast cancer

Scientific Title:Acronym

PhaseII study of Nab-paclitaxel followed by EC as neoadjuvant chemotherapy for the operable breast cancer

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to assess the efficacy and safety of Nab-paclitaxel followed by EC as neoadjuvant chemotherapy for the breast cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Pathological complete response rate

Key secondary outcomes

Response rate, rate of breast conserving surgery, frequency and degree of adverse events, remains rate of peripheral neuropathy, QOL survey, Correlation of the QOL survey results and the pCR rate and the response rate


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 EC100
weekly nab-Paclitaxel
(HER2 negative)
Nab-Paclitaxel(80mg/m2) day1,8,15, every 4 weeks
(HER2 positive)
Nab-Paclitaxel(80mg/m2) day1,8,15
Trastuzumab 2mg/kg day1,8,15,22
(4 mg/kg for the initial dosing)
every 4 weeks

EC
epirubicin 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) Cytological confirmed breast cancer
2) Clinical Stage I-III B
3) Expected to radical operation of post chemotherapy
4) Has measurable region
5) Age 20 or over
6) No prior surgery, radiation, chemotherapy and endocrine therapy
7) Performance Status 0-1
8) Adequate function of important organs(within 14 days before registration)
WBC >=4,000/mm3
Neutrophil >=2,000/mm3
Platelet >=10.0 x 104/mm3
Hemoglobin >=9.0g/dL
AST <=100 IU/L
ALT <=100 IU/L
T-Bil <=1.5mg/dL
Creatinin <=1.5mg/dL

Key exclusion criteria

1) History of hypersensitivity reaction
2) Active double cander
3) Other severe complications, such as infections, diarrhea, uncontrolled angina, myocardial infarction within 6 months, heart failure.
4) Case of contraindication of this drug
5) Patients with peripheral nerve symptoms
6) Pregnant or lactating women, women who are capable of pregnancy, intend to get pregnant
7) Judged ineligible based on physicians' decision

Target sample size

24


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shingo Sakata

Organization

Rakuwakai Otowa Hospital

Division name

Breast oncology department

Zip code


Address

Chinjicho2 Yamashina-ku, Kyoto city, Kyoto, Japan

TEL

+81-75-593-4111

Email

Rakuwadr1198@rakuwadr.com


Public contact

Name of contact person

1st name
Middle name
Last name Shingo Sakata

Organization

Rakuwakai Otowa Hospital

Division name

Breast oncology department

Zip code


Address

Chinjicho2 Yamashina-ku, Kyoto city, Kyoto, Japan

TEL

+81-75-593-4111

Homepage URL


Email

Rakuwadr1198@rakuwadr.com


Sponsor or person

Institute

Rakuwakai Otowa Hospital
Breast oncology department

Institute

Department

Personal name



Funding Source

Organization

Rakuwakai Otowa Hospital

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

2016 Year 07 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

Terminated

Date of protocol fixation

2016 Year 06 Month 21 Day

Date of IRB


Anticipated trial start date

2016 Year 07 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 06 Month 28 Day

Last modified on

2018 Year 05 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026428


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name