A Phase II study of pertuzumab+trastuzumab+capecitabine in Patients with taxans and trastuzumab refractory for advanced or recurrent breast cancer

A Phase II study of pertuzumab+trastuzumab+capecitabine in Patients with taxans and trastuzumab refractory for advanced or recurrent breast cancer - A Phase II study of pertuzumab+trastuzumab+capecitabine in Patients with taxans and trastuzumab refractory for advanced or recurrent breast cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012030

Enrollment

Registered

2013-10-15

Start date

2013-10-15

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

HER2-positive metastatic breast cancer

Interventions

pertuzumab+trastuzumab+capecitabine

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1.Pathologically confirmed invasive breast cancer. 2.>=20years old 3.HER2 positive (3+staining by immunohistochemistry or HER2 geneamplification signal ratio of 2.0 or more by FISH or DISH) confirmed in the invasive component of the primary or metastatic lesion. 4.Patients with taxans (docetaxel/paclitaxel/Nab-paclitaxel) refractory and previously treatments reportable 5.Patients without previous irradiation for terget lesion,but exclude the new lesion from previous irradiation points. 6.ECOG PS 0-2 7.Baseline LVEF>=50% by echocardiography or MUGA 8.Adequate baseline organ and marrow fuction as defined below Absolute neutrophil count >=1500mm3 hemmoglobin >=9.0g/dl platelet count >=100000/mm3 AST/ALT 3 times of the facilities normal level total bilirubin=<1.5mg/dl serum creatinine=<1.5mg/dl (If patient with liver metastatic,5 times of the facilities normal leve to be able to enrolled ) 9.Creatinine clearance>50mL/min.

Exclusion criteria

Exclusion criteria: 1.Patients received capecitabine,pertuzumab. 2.Have hypersensitivity to Trastuzumab. 3.History of allergic reactions for capecitabine or fluoropyrimidines. 4.Patient during the therapy enforcement of immunity or hormon therapy. 5..During pregnancy or lactation. 6.Symptomatic brain metastasis. 7.With uncontrollable hypertension, angina, congestive heart failure, myocardial infection within 1 year, arrhythmia, valvular heart disease. 8.Pulmonary fibrosis or pneumonia. 9.Dyspnea at rest. 10.With pleural effusion, ascites, pericardial effusion. 11Active infection or potentiality infection. 12.Serious drug allergy. 13.Active double cancer. 14.Only bone metastasis. 15.Judged by the investigator to be unfit to be enrolled into the study.

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Progression-free survival Overall survival Clinical benefit rate Time to treatment failure safety profiles	—

Countries

Japan

Contacts

Public ContactTsuyoshi Saito

Saitama Red Cross Hospital Department of breast surgery

tsaito@jcom.home.ne.jp048-852-1111

Outcome results

None listed

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