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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030242
Receipt No. R000034324
Scientific Title Phase II study of nivolumab + bevacizumab + paclitaxel in patients with HER2-negative metastatic breast cancer Nivolumab Evaluation With BEvacizumab And pacliTaxel (NEWBEAT) study (WJOG9917B)
Date of disclosure of the study information 2017/12/04
Last modified on 2019/06/06

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Basic information
Public title Phase II study of nivolumab + bevacizumab + paclitaxel in patients with HER2-negative metastatic breast cancer
Nivolumab Evaluation With BEvacizumab And pacliTaxel (NEWBEAT) study (WJOG9917B)
Acronym Phase II study of nivolumab combination therapy for HER2-negative metastatic breast cancer (WJOG9917B)- NEWBEAT study
Scientific Title Phase II study of nivolumab + bevacizumab + paclitaxel in patients with HER2-negative metastatic breast cancer
Nivolumab Evaluation With BEvacizumab And pacliTaxel (NEWBEAT) study (WJOG9917B)
Scientific Title:Acronym Phase II study of nivolumab combination therapy for HER2-negative metastatic breast cancer (WJOG9917B)- NEWBEAT study
Region
Japan

Condition
Condition HER2-negative metastatic breast cancer untreated with chemotherapy
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of nivolumab + paclitaxel + bevacizumab therapy as the first-line treatment in patients with human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Overall response rate
Key secondary outcomes Safety, disease control rate (DCR), progression free survival (PFS), overall survival (OS)

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 Nivolumab+Paclitaxel+Bevacizumab
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 or cytologically confirmed invasive breast carcinoma.
2)Age of >= 20 years.
3)Women.
4)Patients who are confirmed to be HER2-negative (for IHC 2+, negative being confirmed by the FISH/DISH method).
5)Patients with advanced metastatic breast cancer or inoperable recurrent breast cancer.
6)Chemotherapy-naive patients.
7)Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
8)Patients with a measurable lesion based on the Response Evaluation Criteria in Solid Tumors Revised RECIST guideline version 1.1 (RECIST) in imaging assessed within 28 days prior to the enrollment.
9)A laboratory test performed within 14 days prior to the enrollment meets the following Items:
- Neutrophil count=>1500/mm3
- Platelet count=>10x10000/mm3
- Hemoglobin=>8.0g/dL
- AST(GOT)<=100IU/L (If patients have liver metastasis, <=200IU/L)
- ALT(GPT)<=100IU/L (If patients have liver metastasis, <=200IU/L)
- Total bilirubin<=1.5mg/dL
- Creatinine<=1.5mg/dL
- Meeting either of the followings:
a) Urine protein (test strip) is negative (-) or 1+
b) In the case of urine protein (test strip) is =>2+, 24-hour urine protein should be measured, and urine protein is <=1g/24hrs
10)Well controlled blood pressure (systolic blood pressure of 150mmHg and diastolic blood pressure of 90mmHg controlled by 2 antihypertensives).
11)Life expectancy of > 3 months
12)Written consent signed personally by the patient is obtained after receiving an adequate explanation on the details of the study prior to enrollment in this clinical study.
13)For women of childbearing potential: agreement to remain abstinent and not to breastfeed from the consent of enrollment to at least 5 months after the last dose of drugs.
Key exclusion criteria 1)Patients treated with drug therapy targeting anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, anti-CTLA-4 antibodies or other T-cell co-stimulatory receptors.
2)Patients with a history of infiltrative malignancies within the last 5 years.
3)Patients received taxane chemotherapy within the last 6 months.
4)Patients with metastases to bone only.
5)Patients received molecular targeted therapy or radiotherapy within 14 days before enrollment.
6)Patients received another investigational treatment within 28 days before enrollment.
7)Patients received a live vaccine within 30 days before the first dose of the study drug.
8)Patients required treatment with systemic corticosteroids at a predonine equivalent dose of > 10mg/day or immunosuppressive drugs for active autoimmune disease within 28 days prior to enrollment.
9)Patients with active infection requiring systemic treatment.
10)Patients with concurrent interstitial lung disease/pneumonitis or a history of interstitial lung disease/pneumonitis requiring treatment with systemic corticosteroids.
11)Patients who are pregnant or possibly pregnant or breastfeeding.
12)Patients with HBs antigen-positive or HCV antibody-positive.
13)Patients who are either HIV-1 or HIV-2 antibody-positive.
14)Patients with major cardiovascular disease. Patients with myocardial infarction or acute coronary artery disease, or underwent coronary angioplasty, stenting or bypass surgery within the last 6 months. Patients with NYHA class III to IV congestive heart failure.
15)History of disease or underlying condition:
- uncontrolled diabetes
- peripheral neuropathy (Grade=>2)
- congenital bleeding diathesis or coagulation disorders
- arterial thrombosis or venous thrombosis before 6 months from the enrollment
- gastrointestinal tract perforation
- active peptic ulcer disease or bleeding (Grade =>3)
- other serious conditions such as renal failure or liver failure
Target sample size 51

Research contact person
Name of lead principal investigator
1st name Toshimi
Middle name
Last name Takano
Organization Toranomon Hospital
Division name Department of Medical Oncology
Zip code 105-847
Address 2-2-2, Toranomon, Minato-ku, Tokyo 105-847, Japan
TEL 03-3588-1111
Email takano@toranomon.gr.jp

Public contact
Name of contact person
1st name Yukinori
Middle name
Last name Ozaki
Organization Toranomon Hospital
Division name Department of Medical Oncology
Zip code 105-8470
Address 2-2-2, Toranomon, Minato-ku, Tokyo 105-847, Japan
TEL 03-3588-1111
Homepage URL
Email 1755ozaki@toranomon.gr.jp

Sponsor
Institute Coordinating committee for WJOG 9917B investigator-initiated clinical study
Institute
Department

Funding Source
Organization ONO PHARMACEUTICAL CO., LTD
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor West Japan Oncology Group
Name of secondary funder(s)

IRB Contact (For public release)
Organization Toranomon Hospital IRB
Address 2-2-2, Toranomon, Minato-ku, Tokyo 105-847, Japan
Tel 03-3588-1111
Email chikenjimukyoku@toranomon.gr.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
2017 Year 12 Month 04 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 No longer recruiting
Date of protocol fixation
2017 Year 09 Month 07 Day
Date of IRB
2017 Year 12 Month 28 Day
Anticipated trial start date
2018 Year 02 Month 05 Day
Last follow-up date
2020 Year 10 Month 23 Day
Date of closure to data entry
2020 Year 12 Month 31 Day
Date trial data considered complete
2021 Year 01 Month 31 Day
Date analysis concluded
2021 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 12 Month 04 Day
Last modified on
2019 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034324

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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