UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006547
Receipt number R000007757
Scientific Title Phase II study of q3w nab-paclitaxel in combination with q3w trastuzumab for HER2 positive metastatic breast cancer.
Date of disclosure of the study information 2011/10/16
Last modified on 2019/10/17 08:09:04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Phase II study of q3w nab-paclitaxel in combination with q3w trastuzumab for HER2 positive metastatic breast cancer.

Acronym

Nature study

Scientific Title

Phase II study of q3w nab-paclitaxel in combination with q3w trastuzumab for HER2 positive metastatic breast cancer.

Scientific Title:Acronym

Nature study

Region

Japan


Condition

Condition

Metastatic breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of the effficacy and safety of q3w nab-paclitaxel in combination with q3w trastuzumab for HER2 positive metastatic breast cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Response rate

Key secondary outcomes

Progression-free survival
Safety
Overall survival


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

Abraxane: 260mg/m2, iv, day 1
Every 3 weeks
Trastuzumab: 6mg/kg, iv, day1
Every 3 weeks

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. Histologically confirmed
metastatic breast cancer.
2. Age are more than 20 years old
3. within withiin 2 prior treatment for metastatic breast cancer.
4. With evaluable leasion
5. Performance statu is 0,1,2.
6. Required baseline laboratory data. (within 14 days of registration)
WBC > 4,000 /mm3 or Neu > 2,000/mm3
PLT > 100,000 /mm3
Hb > 9.0 g/dL
ALT and AST < ULNx2.5
ALT and AST < ULNx2.5
T-Bil < 1.5mg/dL
serum creatine < 1.5mg/dL
7. Expected survival time: more than 6 months.
8.Written informed- consent

Key exclusion criteria

1. With history of hypersensitivity reaction for paclitaxel and/or albumin and/or trastuzumab.
2. With severe complications.
3. Pregnant or nursing women.
4. With widespread liver metastases or with dyspnea in pulmonary lymphangitis.
5. With severe complications.
6. With brain metastasis.
7. with uncontrollable hypertension, angina, congestive heart failure, myocardial infection within 1 year, arrhythmia, valvular heart disease.
8. With pulmonary fibrosis or pneumonitis.
9. With dyspnea at rest.
10. With pleural effusion, ascites, pericardial effusion.
11. Doctor's decision not to be registered to this study.

Target sample size

35


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Seiichi Takenoshita

Organization

Fukushima Medical University School of medicine

Division name

Department of Surgery

Zip code


Address

1 Hikariga-oka, Fukushima

TEL

024-547-1259

Email



Public contact

Name of contact person

1st name
Middle name
Last name Tohru Ohtake

Organization

Fukushima Medical University School of medicine

Division name

Department of Surgery, Division of Breast Surgery

Zip code


Address

1 Hikariga-oka, Fukushima

TEL

024-547-1259

Homepage URL


Email

trcyn@cc.fmu.ac.jp


Sponsor or person

Institute

Fukushima Medical University School of medicine

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


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

公立大学法人福島県立医科大学附属病院


Other administrative information

Date of disclosure of the study information

2011 Year 10 Month 16 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

2011 Year 09 Month 30 Day

Date of IRB

2017 Year 04 Month 28 Day

Anticipated trial start date

2011 Year 10 Month 01 Day

Last follow-up date

2018 Year 03 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

2011 Year 10 Month 16 Day

Last modified on

2019 Year 10 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007757


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name