Observational study to examine the efficacy of bevacizumab and paclitaxel combination therapy that targets inoperable or recurrent breast cancer

Observational study to examine the efficacy of bevacizumab and paclitaxel combination therapy that targets inoperable or recurrent breast cancer - PerSeUS-BC02

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000010755

Enrollment

Registered

2013-05-17

Start date

2012-06-06

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

inoperable or recurrent breast cancer

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Patients who were histologically or cytologically diagnosed as breast cancer. 2. Inoperable or recurrent breast cancer patients. 3. Patients with age of 20 years or older at registration 4. HER2 negative (FISH negative or IHC 2+ or less) (need to check HER2 status by FISH if IHC score is 2+) 5. Expression of ER and PgR should be confirmed by immunohistochemical staining, etc. 6. ECOG preformance status (PS 0-2) 7. No sequential use after neoadjuvant/adjuvant chemotherapy. 8. Patients who previously treated with no more than one chemotherapy regimen for metastatic or inoperable recurrent breast cancer *Endocrine therapy not included. 9. Sufficient major organ functions (determined by the attending physician). 10. Agreed to receive the combination therapy with bevacizumab and paclitaxel 11. Written informed consent 12. Patients with brain metastasis are also feasible under strict observation. When brain complications occur, appropriate care should be performed.

Exclusion criteria

Exclusion criteria: 1.Prior therapy with bevacizumab 2. Recurrence during adjuvant chemotherapy 3.History of hypersensitivity to the components of bevacizumab or paclitaxel 4.Women who are pregnant, lactating or declined contraception 5.Congestive heart failure, unstable angina, uncontrolled arrhythmia 6.Uncontrolled hypertension 7.Patients with ptoteinuria (>Grade2) 8.Arterial thromboembolism (stroke, myocardial infarction, etc.) 9.Venous thromboembolism (deep vein thrombosis, pulmonary embolism) 10.Gastrointestinal perforation or severe gastrointestinal fistula 11.Planned surgery within 4w prior to the study 12. nonhealing wound or fracture. 13.Patients considered ineligible by the attending physician

Design outcomes

Primary

Measure	Time frame
Progression Free Survival	—

Secondary

Measure	Time frame
Overall response rate, 1-year survival rate, 2-year survival rate, 3-year survival rate, Safety	—

Countries

Japan

Contacts

Public ContactManabu Futamura

Gifu University Graduate School of Medicine Breast and Molecular Oncology

mfutamur@gifu-u.ac.jp058-230-6000

Outcome results