Effect of Additional pertuzumab for the post treatment in Patients with HER2 positive locally advanced/ metastatic Breast Cancer Who Were Previously Treated with pertuzumab - Phase II study -

Effect of Additional pertuzumab for the post treatment in Patients with HER2 positive locally advanced/ metastatic Breast Cancer Who Were Previously Treated with pertuzumab - Phase II study - - Clinical evaluation of re-administratoin of additional pertuzumab (SBP-08: Beyond pertuzumab study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020837

Enrollment

Registered

2016-02-02

Start date

2015-12-02

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

Add pertuzumab after the progression of the initial HER2 targeting therapy ( trastuzumab with either 1: vinorelbine, 2: paclitaxel or 3: eribulin) . Initial HER2 targeting therapy as

1 vinorelbine 25 mg/ m2 day 1, 8 (q21) trastuzumab 6 mg/ kg day 1 ( induction dose: 8mg/ kg) (q21). 2 paclitaxel 80mg/m2 day 1, 8, 15 (q21) trastuzumab 6 mg/ kg day 1 ( induction dose: 8mg/ kg)

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1 informed consent 2 age >=20 3 locally advanced/ metastatic breast cancer histologically confirmed 4 HER2 breast cancer( FISH positive or IHC 3+) 5 MBC pretreated with pertuzumab containing regimens 6 ECOG PS: 0-2 7 non-hematological AE( CTCAE v4.0-JCOG) <= grade 2 8 survival expectancy >= 3 months 9 with or without evaluable lesions 10 EF>=50 11 untreated with either vinorelbine, paclitaxel or eribulin 12 non major organ dysfunction within the criteria below; for the VNR regimens: 1 neutrophil >=1000/mm3 2 PLT >=75000/mm3 3 Hb >=8.0 g/dL 4 T.Bil <=2 X ULN 5 AST, ALT <=3 X ULN (5 X ULN in the cases of liver metastasis) 6 Cr <= 1.5 mg/dL for the PTX regimens: 1 neutrophil >=1500/mm3 2 PLT >=100000/mm3 3 Hb >=8.0 g/dL 4 T.Bil <=2 X ULN 5 AST, ALT <=3 X ULN (5 X ULN in the cases of liver metastasis) 6 Cr <= 1.5 mg/dL for the ERI regimens: 1 neutrophil >=1500/mm3 2 PLT >=75000/mm3 3 Hb >=8.0 g/dL 4 T.Bil <=2 X ULN 5 AST, ALT <=3 X ULN (5 X ULN in the cases of liver metastasis) 6 Cr <= 1.5 mg/dL

Exclusion criteria

Exclusion criteria: 1 pretreated with all of VNR, PTX and ERI 2 allergic for VNR, PTX, ERI, polyoxyethylene castor oil, CHO or recombinant humanized monoclonal antibody 3 symptomatic brain metastasis 4 pregnancy or breast feeding or unwilling to contraception 5 uncontrolled hypertension, symptomatic heart failure, unstable angina, severe arrhythmia or acute myocardial infarction within 12 months 6 obvious pulmonary fibrosis or interstitial pneumonia 7 EF <50% 8 active infection 9 no other severe comorbidity 10 no another active cancer 11 other inappropriate patients

Design outcomes

Primary

Measure	Time frame
clinical benefit rate	—

Secondary

Measure	Time frame
PFS, OS, response rate, response rate of the initial therapy, safety	—

Countries

Japan

Contacts

Public ContactTaira Naruto

Setouchi Breast Project Comprehensive Support Organization Clinical trial committee

info@setouchi-bp.com086-235-7265

Outcome results

None listed

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