UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019616
Receipt number R000022429
Scientific Title Phase II study of neoadjuvant nab-paclitaxel and trastuzumab for ER negative and HER2 positive breast cancer
Date of disclosure of the study information 2015/11/04
Last modified on 2019/05/07 11:36:36

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Basic information

Public title

Phase II study of neoadjuvant nab-paclitaxel and trastuzumab for ER negative and HER2 positive breast cancer

Acronym

Neoadjuvant nab-PTX and trastuzumab for ER negative and HER2 positive breast cancer

Scientific Title

Phase II study of neoadjuvant nab-paclitaxel and trastuzumab for ER negative and HER2 positive breast cancer

Scientific Title:Acronym

Neoadjuvant nab-PTX and trastuzumab for ER negative and HER2 positive breast cancer

Region

Japan


Condition

Condition

ER negative and HER2 positive breast cancer

Classification by specialty

Hematology and clinical oncology Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluate the efficacy and safety of nab-paclitavel (PTX) and trastuzumab for ER negative and HER2 positive operable (tumor size of 3cm or less and N0) breast cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Pathologic complete response rate (Up to 12 weeks after the protocol therapy)

Key secondary outcomes

Disease free survival
Objective response rate
Pathologocal response rate
Rate of breast conserving surgery
Safety profile


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

Four cycles of nab-PTX 260 mg/m2 with trastuzumab 6 mg/kg (8 mg/kg as the
loading dose).
One year of adjuvant trastuzumab will be
administrated.
Anthracycline regimens may be administered by physician's choice for the case expected to have a high risk of recurrence based on the pathological findings of surgical specimen.
Adjuvant endocrine therapy may be administrated for the case with weakly hormone-sensitive (1-9% of positive cells) tumor.

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 invasive breast cancer
2. Tumor size of 3cm or less and N0
3. Hormone receptors have been identified as negative
4. HER2 positive confirmed by IHC 3+ or FISH+
5. LVEF > 50% by echocardiogram or MUGA
6. Adequate EKG
7. No prior treatment for breast cancer
8. PS 0-1
9. Required baseline laboratory data
WBC > 4,000/mm3 and Neut > 2,000/mm3
PLT > 100,000/mm3
Hb > 9.0g/dl
AST and ALT < ULNx2.5
T-Bil < 1.5mg/dl
Serum creatinin < 1.5mg/dl
10. Written informed consent

Key exclusion criteria

1. With history of hypersensitivity reaction for important drug in this study
2. With history of invasive breast cancer
3. Bilateral invasive breast cancer
4. Patients with medical conditions that renders them intolerant to primary chemotherapy and related treatment, including infection, diarrhea, intestinal paralysis, severe Diabetes Mellitus
5. Positive for HBs antigen or HCV antibody
6. With history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction, poorly controlled hypertension
7. With severe edema
8. With severe peripheral neuropathy
9. With severe psychiatric disorder
10. Pregnant or nursing women
11. The case that is judged to be unsuitable for this study by physician

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Mitsuhiko
Middle name
Last name Iwamoto

Organization

Osaka Medical College Hospital

Division name

Breast and endocrine surgery

Zip code

5698686

Address

2-7 Daigaku-machi, Takatsuki-city, Osaka 569-8686, Japan

TEL

0726831221

Email

sur067@osaka-med.ac.jp


Public contact

Name of contact person

1st name Satoru
Middle name
Last name Tanaka

Organization

Osakaminami Medical Center

Division name

Breast surgery

Zip code

5868521

Address

2-1 Kidohigashicho, Kawachinagano, Osaka 586-8521, Japan

TEL

0721-53-5761

Homepage URL


Email

sur112@osaka-med.ac.jp


Sponsor or person

Institute

Osaka Medical College

Institute

Department

Personal name



Funding Source

Organization

None

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

Review board of Osaka Medical College

Address

2-7 Daigaku-machi, Takatsuki-city, Osaka 569-8686, Japan

Tel

0726831221

Email

rinri@osaka-med.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

NCT02598310

Org. issuing International ID_1

ClinicalTrials.gov

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2015 Year 11 Month 04 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

18

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

Main results already published

Date of protocol fixation

2015 Year 08 Month 27 Day

Date of IRB

2015 Year 11 Month 02 Day

Anticipated trial start date

2015 Year 11 Month 04 Day

Last follow-up date

2019 Year 04 Month 02 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 11 Month 03 Day

Last modified on

2019 Year 05 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022429


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name