Cohort study evaluating efficacy of bevacizumab plus paclitaxel in patients with HER2-negative inoperable or metastatic breast cancer(JBCRG-C05)

Cohort study evaluating efficacy of bevacizumab plus paclitaxel in patients with HER2-negative inoperable or metastatic breast cancer(JBCRG-C05) - JBCRG-C05(B-SHARE)

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000009086

Enrollment

750

Registered

2012-10-12

Start date

2012-11-01

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-negative inoperable or metastatic breast cancer

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Agreed to receive combination of bevacizumab and paclitaxel 2. Patients have been confirmed with breast cancer histologically or cytologically 3. Histologically confirmed invasive breast cancer by biopsy 4. HER2 negative; FISH negative or IHC 2+ or less (need to check negative status by FISH if IHC score is 2+) 5. Expression status of ER and PgR has been confirmed in immunohistochemical staining, etc. 6. ECOG preformance status (PS.): 0-3 7. Study treatment is the first or second line chemotherapy* in inoperable metastatic breast cancer *Endocrine therapy not included 8. Sufficient bone marrow and major organ functions (determined by the attending physician). 9. Written informed consent

Exclusion criteria

Exclusion criteria: 1.History of hypersensitivity to the components of bevacizumab and paclitaxel 2.Hypersensitivity to preparations containing polyoxyethylene castor oil 3.History of hemoptysis (hemoptysis of fresh blood of more than 2.5 ml) 4.Complications of infection 5.Women who are pregnant, lactating or declined contraception 6.Under treatment with administration of disulfiram, cyanamide, carmofur or procarbazine hydrochloride 7.Symptomatic brain metastases 8.Uncontrolled hypertension 9.Arterial thromboembolism (stroke, myocardial infarction, etc.) 10.Venous thromboembolism (deep vein thrombosis, pulmonary embolism) 11.Urine protein over 2+ 12.Gastrointestinal perforation and severe fistula 13.Patients considered ineligible by the attending physician

Design outcomes

Primary

Measure	Time frame
Overall Survival: OS	—

Secondary

Measure	Time frame
Response Rate: RR Progression Free Survival: PFS Safety	—

Countries

Japan

Contacts

Public ContactJun Fukase

Japan Breast Cancer Research Group (JBCRG) Head office

office@jbcrg.jp03-6264-8873

Outcome results