UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030242 |
|---|---|
| Receipt number | 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 | 2023/08/08 14:05:56 |
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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
The Cancer Institute Hospital Of JFCR
Division name
Breast Oncology Center
Zip code
135-8550
Address
3-8-31, Ariake, Koto, Tokyo 135-8550, Japan
TEL
03-3520-0111
toshimi.takano@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Yukinori |
| Middle name | |
| Last name | Ozaki |
Organization
The Cancer Institute Hospital Of JFCR
Division name
Breast Oncology Center
Zip code
135-8550
Address
3-8-31, Ariake, Koto, Tokyo 135-8550, Japan
TEL
03-3520-0111
Homepage URL
yukinori.ozaki@jfcr.or.jp
Sponsor or person
Institute
Coordinating committee for WJOG 9917B investigator-initiated clinical study
Institute
Department
Personal name
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
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
None
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0959804922002933
Number of participants that the trial has enrolled
57
Results
For patients with HER2-negative metastatic breast cancer, nivolumab plus bevacizumab and paclitaxel combination therapy showed the promising efficacy and toxicities were manageable.
Results date posted
| 2023 | Year | 08 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 06 | Month | 18 | Day |
Baseline Characteristics
Patients with HER2-negative metastatic breast cancer who were chemotherapy-naive, 20 years old and more, PS 0-1 and metastatic or inoperable were enrolled.
Participant flow
Fifty-seven patients were enrolled. Nivolumab plus bevacizumab and paclitaxel combination therapy was administrated to all patients enrolled.
Efficacy analysis set was 56 patients (exclude one ineligible patient because of no target lesion assessed by central review) and 70% of patients (39/56) in efficacy analysis set had HR-positive breast cancer. Safety analysis set was 57 patients, all of patients enrolled.
Adverse events
Major adverse events were alopecia, nausea, diarrhea, arthralgia, neutropenia, peripheral neuropathy.
Outcome measures
Overall response rate (independent central review): 70% (39/56: 95%CI:55.9 - 81.2%).
Progression free survival (independent central review): 13.6 months (median) (95% CI:10.8 - 15.8 months).
Overall survival: 32.6 months (median) (95% CI:26.1 months - NR).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2021 | Year | 10 | Month | 23 | Day |
Date of closure to data entry
| 2022 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 11 | Day |
Date analysis concluded
| 2022 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 04 | Day |
Last modified on
| 2023 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034324
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