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Evaluation of efficacy and safety of combinationtherapy with trastuzumab and eribulin for HER2-positive inoperableness or metastatic breast cancer

Evaluation of efficacy and safety of combinationtherapy with trastuzumab and eribulin for HER2-positive inoperableness or metastatic breast cancer - Combination therapy of trastuzumab and eribulin

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000007113
Enrollment
35
Registered
2013-12-31
Start date
2011-12-01
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

inoperableness or metastatic breast cancer

Interventions

Treatment with trastuzumab (8mg/kg followed by 6mg/kg, q3w, or 4mg/kg followed by 2mg/kg weekly) and eribulin (on day 1 and 8 every 3 weeks). Continue to disease progression.

Sponsors

Wakayama Medical University Department of Thoracic and Cardiovascular Surgery
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: (1)With serious drug allergy (2) Systemic infection (3)Control of pleural effusion,ascites and pericardial fluid (4)Clinical symptoms with brain metastasis (5) Severe complications 1) Control of bad heart disease 2) Myocardial infarction within 6 months 3) Cirrhosis 4) Between interstitial Pneumonitis and pulmonary fibrosis 5) Bleeding tendency (6) Active cancer (7) Pregnancy, breast feeding or wish of future bearing (8) Long-term corticosteroid therapy (9) Wide range of radiation therapy (10)Refusal of blood transfusion (11) Patients considered inappropriate by the study investigator

Exclusion criteria

Exclusion criteria: (1)With serious drug allergy (2) Systemic infection (3) Control of pleural effusion, ascites and pericardial fluid (4)Clinical symptoms with brain metastasis (5) Severe complications 1) Control of bad heart disease 2) Myocardial infarction within 6 months 3) Cirrhosis 4) Between interstitial Pneumonitis and pulmonary fibrosis 5) Bleeding tendency (6) Active cancer (7) Pregnancy, breast feeding or wish of future bearing (8) Long-term corticosteroid therapy (9) Wide range of radiation therapy (10)Refusal of blood transfusion (11) Patients considered inappropriate by the study investigator

Design outcomes

Primary

MeasureTime frame
Overall Response Rate

Secondary

MeasureTime frame
Time to Treatment Failure Progression-Free Survival Overall Survival Adverse event

Countries

Japan

Contacts

Public ContactShoji Oura

Wakayama Medical University Department of Thoracic and Cardiovascular Surgery

073-447-2300

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026