UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006838 |
|---|---|
| Receipt number | 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 13:37:22 |
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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
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
ymiyoshi@hyo-med.ac.jp
Sponsor or person
Institute
Department of Breast and Endocrine Surgery, Hyogo College of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007281
