A phase II trial of pertuzumab and trastuzumab in combination with capecitabine in patients with metastatic breast cancer who received prior trastuzumab combination chemotherapy.

A phase II trial of pertuzumab and trastuzumab in combination with capecitabine in patients with metastatic breast cancer who received prior trastuzumab combination chemotherapy. - A phase II trial of pertuzumab and trastuzumab in combination with capecitabine in patients with metastatic breast cancer who received prior trastuzumab combination chemotherapy.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012208

Enrollment

Registered

2013-11-05

Start date

2013-11-05

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

Pertuzumab:840mg/body intravenously administred on day 1 every 3 weeks (loading dose:840mg/body) Trastuzumab:6mg/kg intravenously administred on day 1 every 3 weeks (loading dose:8mg/kg) Capecitabi

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed breast cancer. 2) HER2-positive(3+ staining by IHC or HER2 gene amplification by FISH) metastatic breast cancer. 3) Patients with at least one or more prior chemotherapy combined trastuzumab. 4) No prior treatment by capecitabine for present primary breast cancer. 5) Patients with measurable lesion. 6) Left ventricle ejection fraction 50% or over by cardiac sonography within 28 days prior to entry. 7) Age between 20 and 70 years. 8) ECOG performance status 0 to 2. 9) Expected survival longer than 3 months. 10) Sufficient functions of important organs WBC>=3,000/mm3 Neurtophils>=1,500/mm3 Platelets>=80,000/mm3 Hemoglobin>=9.0g/dl AST<=2.0 X ULN ALT<=2.0 X ULN Total bilirubin<=2.0mg/dl Creatinine<=2.0mg/dl 11) All of HBs antigen, HBs antibody, HBc antibody and HCV antibody are negative. 12) Written informed consent to participate.

Exclusion criteria

Exclusion criteria: 1) History of hypersensitivity reaction 2) Brain metastasis 3) Pleural effusion, ascites, and pericardial fluid requiring treatment 4) Active another cancer 5) Active infection 6) Other severe complications, such as heart failure, interstitial pneumonia and renal failure with clinically problem 7) Required treatment with steroid 8) Pregnant or possibility pregnancy or nursing women 9) Mental disorder which become problem on clinical practice 10) Physician judged improper to entry this trial

Design outcomes

Primary

Measure	Time frame
Response Rate	—

Secondary

Measure	Time frame
Progression-free survival Overall survival Safety	—

Countries

Japan

Contacts

Public ContactKeisuke Miwa

Kurume University Hospital Cancer Multidisciplinary Treatment Center

miwakeisuke@gmail.com0942-35-3311

Outcome results

None listed

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