Phase II trial with abraxane and trastuzumab for advanced/recurrent HER2-positive breast cancer

Phase II trial with abraxane and trastuzumab for advanced/recurrent HER2-positive breast cancer - Phase II trial with abraxane and trastuzumab for advanced/recurrent HER2-positive breast cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010845

Enrollment

Registered

2013-06-15

Start date

2013-06-15

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

Breast cancer

Interventions

Administration of abraxane with a dose of 260 mg/m2 for days1 of 21 day course. Administration of trastuzumab every 3 weeks with a starting dose of 8 mg/kg followed by 6 mg/kg as the second and subseq

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Females with breast cancer which is confirmed to be invasive breast cancer by histological or cytological examination. 2. Advanced/reccurent HER2-positive breast cancer patients with clinical stage IIIb, IIIc, or IV. 3. Patients with a lesion allowing RECIST (ver.1.1) measurement by imaging examinations such as CT or MRI. 4. HER2(3+) by immunohistochemical or positive by fluorescence in situ hybridization methods. 5. Patients with a performance status (ECOG) of 0, 1, or 2 6. Left ventricular ejection fraction (LVEF) is equal or greater than 55% measured by cardiac ultrasonography (or MUGA scan). 7. Patients with adequately maintained organ functions and fulfilling the following conditions within 7 days before registration. (1)Neutrophil>=1,500/mm3 (2)Platelet>=100,000/mm3 (3)Hb>=9.0g/dL (4)T-BIL<=2.0mg/dL (5)AST, ALT <=100IU/L (6)Serum creatinine <= 1.5mg/dL 8. Patients expected to survive for 6 months or more. 9. Patients not have QTc prolongation by electrocardiogram (QTc: less than 470msec). 10. Patients who provided written informed consent by themselves in principle to participate in this trial.

Exclusion criteria

Exclusion criteria: 1. Patients with active double cancer with less than 5years desease free intervals except for dissected carcinoma in situ or intramucosal cancer. 2. Patients with a past history of interstitial pneumonitis, pulmonary fibrosis or severe emphysema. 3. Patients with brain metastases treatment is required at the time of registration. 4. Patients with serious co-morbidities (1)Uncontrolled diabates (2)Uncontrolled hypertension (3)Myocardial infarction within 24 weeks prior to registration, unstable angina, congestive heart failure, myocardial infarction or ventricular arrhythmia requiring medication. (4)Ischemic heart disease, arrhythmias, valvular disease requiring medication. (5)Liver dysfunction(jaundice) (6)Renal dysfunction (7)Active infection or fever suspicious of infection. (8)Other serious complications 5. Pregnant women, nursing mothers, women with possibility of pregnancy or women with no intention to contraception. 6. Other patients who were considered by the primary care physician to be inappropriate as subjects of this trial

Design outcomes

Primary

Measure	Time frame
clinical benefit	—

Countries

Japan

Contacts

Public ContactAkira Tangoku

The University of Tokushima graduate school Department of Thoracic, Endocrine surgery and Oncology

tangoku@clin.med.tokushima-u.ac.jp088-633-7143

Outcome results

None listed

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