Observational study of paclitaxel with Bevacizumab for advanced or recurrent breast cancer(SBCCSG-28)

Observational study of paclitaxel with Bevacizumab for advanced or recurrent breast cancer(SBCCSG-28) - Observational study of paclitaxel with Bevacizumab for advanced or recurrent breast cancer(SBCCSG-28)

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000009090

Enrollment

Registered

2012-10-12

Start date

2012-10-12

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

advanced or recurrent breast cancer

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1.Treatment with Bevacizumab planned case 1-1.Histologically diagnosed with uniateral primary or recurrent breast cancer 1-2.>=20years old 1-3.No previous treatment with Bevacizumab 1-4.If hospital need written informed consent,is taken 2.In treatment with Bevacizumab case 2-1.Histologically diagnosed with uniateral primary or recurrent breast cancer 2-2.>=20years old 2-3.During treatment with Bevacizumab 2-4.If hospital need written informed consent,is taken 3.After treatment with Bevacizumab case 3-1.Histologically diagnosed with uniateral primary or recurrent breast cancer 3-2.>=20years old 3-3.Afer treatment with Bevacizumab 3-4.If hospital need written informed consent,is taken

Exclusion criteria

Exclusion criteria: Only treatment with Bevacizumab planned case 4-1.Have hypersensitivity to Bevacizumab 4-2.During pregnancy or lactation 4-3.Patients receiving anticoagulant therapy 4-4.Daily treatment with hight-dose aspirin(>=325mg/day) or non-steroidal anti-inflammatory medications for chronic inflammatory disease 4-5.Bleeding tendency(including significant hemoptysis or pulmonary tumor cavitation and necrosis),(INR>=1.5 within two weeks prior to entry) 4-6.Uncontrolled peptic ucer 4-7.Perforation of gastrointestional tract within one year 4-8.Renal failure to treated,2+ or higher proteinuria within two weeks prior to entry 4-9.Uncontrolled hypertension 4-10.Clinically significant cardiovascular disease(>=Grade2 according to the Common Toxicity Criteria of the National Cancer Institute,version 4), clinically important echocardiographic findigs,or past or current history(within the last one year)of myocardial infarction 4-11.Not appropriate for the study at the physician's assessment

Design outcomes

Primary

Measure	Time frame
time to treatment failure	—

Secondary

Measure	Time frame
overall survival	—

Countries

Japan

Contacts

Public ContactToshihiro Kai

Saitama Breast Cancer Clinical Study Group (SBCCSG) Secretariat Division (Shintoshin Ladies' MammoClinic)

toshikai@sbccsg.org048-600-1722

Outcome results