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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006838
Receipt No. R000007281
Scientific Title Multicenter pahse II tiral of combination therapy using abraxane and trastuzumab +-pertuzumab for HER2-positive locally advanced or metastatic breast cancer
Date of disclosure of the study information 2011/12/06
Last modified on 2020/03/15

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Basic information
Public title Multicenter pahse II tiral of combination therapy using abraxane and trastuzumab +-pertuzumab for HER2-positive locally advanced or metastatic breast cancer
Acronym Combination therapy of abraxane and trastuzumab+- pertuzumab
Scientific Title Multicenter pahse II tiral of combination therapy using abraxane and trastuzumab +-pertuzumab for HER2-positive locally advanced or metastatic breast cancer
Scientific Title:Acronym Combination therapy of abraxane and trastuzumab+- pertuzumab
Region
Japan

Condition
Condition Locally advanced or metastatic breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of efficacy and safety of combination therapy with abraxane and trastuzumab +- pertuzumabfor HER2-positive locally advanced or metastatic breast cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes response rate
Key secondary outcomes safety, progression-free survival, 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 Treatment with Abraxane (260mg/m2, q3w) and trastuzumab (8mg/kg followed by 6mg/kg, q3w, or 4mg/kg followed by 2mg/kg weekly) +- pertuzumabu(840mg followed by 420mg). Continue to disease progression.
Treatment with parjet is permitted.
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) With evaluable lesion
3) Female between 20 and 75 years old
4) Primary or metastatic region is HER 2 positive: either 3+ over-expression by IHC or positive by FISH
5) Patients who have passed the following periods from previous treatment
in case of operation or radiation therapy, 21 days are needed. in case of endocrine therapy, 14 days from the final administration are needed.
6) PS: 0-1 (ECOG)
7) Baseline left ventricular ejection fraction (LVEF) is >50% measured by echocardiography or MUGA scan.
8) Sufficient organ function meeting following criteria:
Leukocyte >=4000 mm3
Neutrophil >=2000 mm3
Platelet >=100000 mm3
Hemoglobin >=9.0g/dL
AST (GOT) <=2.5 x upper limit of normal (ULN)
ALT (GPT) <=2.5 x upper limit of normal (ULN)
Serum total bilirubin <=1.5 mg/dL
Serum creatinine <=1.5 mg/dL
9) Expected survival time more than 3 months
10) Signed written informed consent
Key exclusion criteria 1) With history of hypersensitivity reaction for paclitaxel, trastuzumab, and pertuzumab.
2) With serious drug allergy
3) Pregnant or nursing women
4) With active another cancer
5) With widespread liver metastases or pulmonary lymphangitis with dyspnea
6) With brain metastasis with symptom
7) With uncontrollable hypertension, angina pectoris, congestive heart failure, myocardial infection within 1 year, arrhythmia that need treat, valvular heart disease
8) Poorly controlled diabetes
9) With pulmonary fibrosis or pneumonitis
10) With dyspnea at rest (due to metastatic lung lesion and cardiovascular disease)
11) With pleural effusion, ascites, and pericardial effusion that need treat
12) Infection or possible infection associated with clinical symptoms such as fever
13) Patients have active hepatitis type B
14) Cases who physician judged improper to entry this trial
Target sample size 25

Research contact person
Name of lead principal investigator
1st name Yasuo
Middle name
Last name Miyoshi
Organization Hyogo College of Medicine
Division name Department of Breast and Endocrine Surgery
Zip code 663-8501
Address Mukogawa 1-1, Nishinomiya, Hyogo
TEL 0798-45-6374
Email ymiyoshi@hyo-med.ac.jp

Public contact
Name of contact person
1st name Yasuo
Middle name
Last name Miyoshi
Organization Department of Breast and Endocrine Surgery
Division name Surgery
Zip code 663-8501
Address Mukogawa 1-1, Nishinomiya, Hyogo
TEL 0798-45-6374
Homepage URL
Email ymiyoshi@hyo-med.ac.jp

Sponsor
Institute Department of Breast and Endocrine Surgery, Hyogo College of Medicine
Institute
Department

Funding Source
Organization Department of breast and endocrine surgery, Hyogo College of Medicine
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 Institutional Review Board of Hyogo College of Medicine
Address Mukogawa 1-1, Nishinomiya City
Tel 0798456374
Email rinri@hyo-med.ac.jp

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
2011 Year 12 Month 06 Day

Related information
URL releasing protocol Unpublished
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/30326862
Number of participants that the trial has enrolled 21
Results
Retrospective-prospective study was conducted with eribulin or nab-paclitzxel + trastuzumab + pertuzumab. Progression-free survival was significantly improved in patients with baseline absolute lymphocyte count more than 1500 (p=0.0106).
Results date posted
2020 Year 03 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2018 Year 10 Month 16 Day
Baseline Characteristics
HER2-positive breast cancer treated with trastuzumab and pertuzumab
Participant flow
Recruited by retrospectively
Adverse events
Adverse events grade 3 were decrease of white blood cells, neutrophils, anemia, febrile neutrophils, abnormal ALT, arthralgia, peripheral neuropathy.
Outcome measures
Response rate was 52%, clinical benefit rate was 67%, disease control rate was 86%.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 06 Month 27 Day
Date of IRB
2011 Year 07 Month 08 Day
Anticipated trial start date
2011 Year 09 Month 01 Day
Last follow-up date
2016 Year 07 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 12 Month 05 Day
Last modified on
2020 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007281

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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