UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035869
Receipt number R000040850
Scientific Title Phase I and II trial of combination therapy using nab-Paclitaxel+Pertuzumab+Trastuzumab for HER2 positive metastatic breast cancer
Date of disclosure of the study information 2019/04/01
Last modified on 2019/02/13 19:23:24

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Basic information

Public title

Phase I and II trial of combination therapy using nab-Paclitaxel+Pertuzumab+Trastuzumab for HER2 positive metastatic breast cancer

Acronym

Combination therapy of nab-Paclitaxel+Pertuzumab+Trastuzumab

Scientific Title

Phase I and II trial of combination therapy using nab-Paclitaxel+Pertuzumab+Trastuzumab for HER2 positive metastatic breast cancer

Scientific Title:Acronym

Combination therapy of nab-Paclitaxel+Pertuzumab+Trastuzumab

Region

Japan


Condition

Condition

metastatic breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of safety and efficacy of combination therapy using nab-Paclitaxel+Pertuzumab+Trastuzumab for HER2 positive metastatic breast cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

time to treatment failure

Key secondary outcomes

safety(after the first cycle)
response rate (best effect)


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

Treatment with nab-Paclitaxel (260mg/m2, q3w), Pertuzumab (840mg followed by 420mg, q3w) and Trastuzumab (8mg/kg followed by 6mg/kg, 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

75 years-old >

Gender

Female

Key inclusion criteria

1.Histologically or cytologically confirmed locally advanced breast cancer or metastatic breast cancer
2.Primary or metastatic region is HER2 positive: either 3+ over-expression by IHC or positive by FISH
3.With or without evaluable lesion
4.Female between 20 and 75 years old
5.Baseline left ventricular ejection fraction (LVEF) is >50% measured by echocardiography or MUGA scan.
6.PS: 0-2 (ECOG)
7.Expected survival time more than 6 months
8.Signed written informed consent

Key exclusion criteria

1.Without previous chemotherapy
2.With brain metastasis with symptom
3.With active another cancer
4.With uncontrollable hypertension, angina pectoris, congestive heart failure, myocardial infection within 6 months, arrhythmia that need treat, valvular heart disease
5.With dyspnea at rest due to metastatic lung lesion
6.Insufficient organ function meeting following criteria
Neutrophil <1500/mm2
Platelet <100000/mm2
Hemoglobin <8.0g/dL
AST(GOT)>100IU/L (with liver function disorder by metastasis)
ALT (GPT) >100IU/L (with liver function disorder by metastasis)
Serum total bilirubin <2.0mg/dL
Serum creatinine >2.0mg/dL or 177umol/L
7.With uncontrollable systemic disease (cardiovascular/pulmonary/metabolic, protracted wound healing, ulcer and bone fracture)
8.With uncontrollable hypercalcemia even by Bisphosphonate or denosumab
9.Pregnant or nursing women
10.Infection or possible infection associated with clinical symptoms
11.With history of hypersensitivity reaction for paclitaxel, trastuzumab, and pertuzumab.
12.Cases who physician judged improper to entry this trial

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akira Tangoku

Organization

The University of Tokushima Graduate School

Division name

Depertment of Thoracic, Endocrine surgery and Oncology, Institute of Health Bioscience

Zip code


Address

3-18-15 Kuramoto-cho, Tokushima City, Tokushima, 770-8503, Japan

TEL

088-633-7143

Email

tangoku@tokushima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masami Morimoto

Organization

The University of Tokushima Graduate School

Division name

Depertment of Thoracic, Endocrine surgery and Oncology, Institute of Health Bioscience

Zip code


Address

3-18-15 Kuramoto-cho, Tokushima City, Tokushima, 770-8503, Japan

TEL

088-633-7143

Homepage URL


Email

twop8air@tokushima-u.ac.jp


Sponsor or person

Institute

The University of Tokushima Graduate School, Depertment of Thoracic, Endocrine surgery and Oncology, Institute of Health Bioscience

Institute

Department

Personal name



Funding Source

Organization

The University of Tokushima Graduate School, Depertment of Thoracic, Endocrine surgery and Oncology, Institute of Health Bioscience

Organization

Division

Category of Funding Organization

Other

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

2019 Year 04 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

Preinitiation

Date of protocol fixation

2019 Year 02 Month 15 Day

Date of IRB


Anticipated trial start date

2019 Year 04 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

2019 Year 02 Month 13 Day

Last modified on

2019 Year 02 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040850


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name