Efficacy and safety of eribulin in combination with trastuzumab and pertuzumab for HER2-positive advanced breast cancer

Efficacy and safety of eribulin in combination with trastuzumab and pertuzumab for HER2-positive advanced breast cancer - KOEB2 trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000034477

Enrollment

Registered

2018-11-01

Start date

2018-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
overall response rate: ORR	—

Secondary

Measure	Time frame
progression-free survival: PFS overall survival: OS adverse events	—

Countries

Japan

Contacts

Public ContactTakamichi Yokoe

Keio University School of Medicine Department of Surgery

takamichi.yokoe@gmail.com03-3353-1211

Outcome results