UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011048
Receipt number R000012931
Scientific Title Phase II study of Nab-paclitaxel followed by FEC as neoadjuvant chemotherapy for the operable breast cancer
Date of disclosure of the study information 2013/06/26
Last modified on 2019/02/04 18:16:36

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Basic information

Public title

Phase II study of Nab-paclitaxel followed by FEC as neoadjuvant chemotherapy for the operable breast cancer

Acronym

Phase II study of Nab-paclitaxel followed by FEC as neoadjuvant chemotherapy for the operable breast cancer

Scientific Title

Phase II study of Nab-paclitaxel followed by FEC as neoadjuvant chemotherapy for the operable breast cancer

Scientific Title:Acronym

Phase II study of Nab-paclitaxel followed by FEC 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 was to assess the efficacy and safety of Nab-paclitaxel followed by FEC as neoadjuvant chemotherapy for the operable breast cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

pathological complete response rate

Key secondary outcomes

adverse event, quasi pathological complete response rate, response rate, rate of breast conserving surgery


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 FEC100

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

FEC
5-FU 100mg/m2, 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-IIIB
3) Expected to radical cure by operation and neoadjuvant chemotherapy
4) Has measurable region
5) Age 20 or over
6) No prior surgery, radiation, chemotherapy and endocrine therapy
7) Adequate function of important organs (within 14 days before registaration)
1. WBC: >=4,000/mm3
2. Neutrophil: >=2,000/mm3
3. Platelet: >=100,000/mm3
4. Hemoglobin: >=9.0g/dL
5. T-Bil <= ULN x 2.5
6. AST <= ULN x 1.5
7. ALT <= ULN x 1.5
8. Creatinin <= 1.5mg/dL
8) ECOG performance status 0-1
9) Written informed consent

Key exclusion criteria

1) History of hypersensitivity reaction
2) Active double cancer
3) Other severe complications, such as uncontrolled diabetes mellitus, uncontrolled angina, myocardial infarction within 6 months, heart failure.
4) Severe mental disorder
5) Sever bone marrow suppression, renal dysfunction, liver dysfunction
6) Has watery diarrhea
7) Active infection or potentiality infection
8) History of hypersensitivity for albumin
9) Grade2 or grater peripheral neuropathy
10) Pregnant or lactating women, women who are capable of pregnancy, intend to get pregnant
11) Judged ineligible based on physicians' decision

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hirohito Seki

Organization

Kitasato University Kitasato Institute Hospital

Division name

Breast Center

Zip code


Address

Shirokane5-9-1 Minato-ku, Tokyo

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kitasato University Kitasato Institute Hospital

Division name

Breast Center

Zip code


Address

Shirokane5-9-1 Minato-ku, Tokyo

TEL


Homepage URL


Email



Sponsor or person

Institute

Kitasato University Kitasato Institute Hospital

Institute

Department

Personal name



Funding Source

Organization

Kitasato University Kitasato Institute 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

2013 Year 06 Month 26 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

2013 Year 04 Month 12 Day

Date of IRB


Anticipated trial start date

2013 Year 05 Month 21 Day

Last follow-up date


Date of closure to data entry

2019 Year 02 Month 04 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 06 Month 26 Day

Last modified on

2019 Year 02 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012931


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name