Unique ID issued by UMIN | UMIN000034477 |
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Receipt number | R000037970 |
Scientific Title | Efficacy and safety of eribulin in combination with trastuzumab and pertuzumab for HER2-positive advanced breast cancer |
Date of disclosure of the study information | 2018/11/01 |
Last modified on | 2020/10/27 20:33:31 |
Efficacy and safety of eribulin in combination with trastuzumab and pertuzumab for HER2-positive advanced breast cancer
KOEB2 trial
Efficacy and safety of eribulin in combination with trastuzumab and pertuzumab for HER2-positive advanced breast cancer
KOEB2 trial
Japan |
Eligible patients were those with HER2-positive advanced breast cancer who had previously received trastuzumab (HER) + pertuzumab (PER) + taxanes and T-DM1, followed by HER + PER + eribulin.
Hematology and clinical oncology | Surgery in general | Breast surgery |
Adult |
Malignancy
NO
To clarify the efficacy and safety of HER + PER + eribulin for patients with HER2-positive advanced breast cancer who had previously received trastuzumab (HER) + pertuzumab (PER) + taxanes and T-DM1.
Efficacy
overall response rate: ORR
progression-free survival: PFS
overall survival: OS
adverse events
Observational
Not applicable |
Not applicable |
Female
1 female patients with diagnosis of breast cancer by histological or cytological examination.
2 ECOG performance status (PS) 0-2
3 with measurable disease lesion by RECIST
4 patients with HER2-positive advanced breast cancer who had previously received trastuzumab (HER) + pertuzumab (PER) + taxanes and T-DM1 (other additional chemotherapy and endocrine therapy is allowed)
5 without previous eribulin treatment
6 with normal organ function
fulfill the criteria below of laboratory data in 7 days before register
6-1. neutrophils: more than 1,500/mm3
6-2. platelets: more than 100,000mm3
6-3. Hb: more than 9.0g/dL
6-4. total bilirubin: less than 2.0 mg/dL
6-5. AST (GOT), ALT (GPT), ALP: less than 2.5 ULN
6-6. serum creatinine: less than 1.5 mg/dL
7 prognosis of more than 3 months is expected
8 no clinical problem with ECG
9 who agreed to register in this trial with written consent
1 infection
2 severe allergy for medication
3 severe heart, renal, liver dysfunction
4 interstitial pneumonia or pulmonary fibrosis
5 large amount of pleural effusion or ascites
6 hypertension or diabetes that is poorly controlled
7 under steroid therapy
8 pregnant woman
9 who received transfusion, blood products, and hematopoietic factor products within 7 days
10 active double cancer (simultaneous double cancer and metachronous cancer within 5 years except for carcinoma in situ and intramucosal cancer)
11 history of psychiatric or CNS disorders which casts clinical problems
12 diagnosis or suspect of brain metastasis
13 engaging in other clinical trials
14 when responsible doctors made a judgement of inappropriate patient
35
1st name | Tetsu |
Middle name | |
Last name | Hayashida |
Keio University School of Medicine
Department of Surgery
161-8582
35 Shinanomachi Shinjuku, Tokyo, Japan
03-3353-1211
tetsu@keio.jp
1st name | Takamichi |
Middle name | |
Last name | Yokoe |
Keio University School of Medicine
Department of Surgery
160-8582
35 Shinanomachi Shinjuku, Tokyo, Japan
03-3353-1211
takamichi.yokoe@gmail.com
Keio University School of Medicine
None
Other
Keio University School of Medicine
35 Shinanomachi Shinjuku, Tokyo, Japan
03-3353-1211
med-rinri-jimu@adst.keio.ac.jp
NO
2018 | Year | 11 | Month | 01 | Day |
Unpublished
Preinitiation
2018 | Year | 07 | Month | 05 | Day |
2018 | Year | 11 | Month | 01 | Day |
2025 | Year | 11 | Month | 01 | Day |
Registration period: 2 years
Follow-up period: 5 years
2018 | Year | 10 | Month | 13 | Day |
2020 | Year | 10 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037970
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