A phase II study of Paclitaxel combined with Bevacizumab in HER2 negative metastatic Breast Cancer

A phase II study of Paclitaxel combined with Bevacizumab in HER2 negative metastatic Breast Cancer - KBCOG 12

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008140

Enrollment

Registered

2012-06-12

Start date

2012-04-01

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

metastatic Breast Cancer

Interventions

paclitaxel 90mg/mm2, day 1, 8, 15 bevacizumab 10mg/kg, day 1, 15 Treatment is administered every 4 weeks until evidence of progression, unacceptable toxicity, patient refusal.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed primary breast cancer 2) Age>=20, <=80 3) ECOG PS: 0-1 4) Measurable lesion 5) Primary chemotherapy refractory 6) Without the symptomatic brain metastasis 7) Without paclitaxel for previous treatment (Eligible if paclitaxel are used in neo-adjuvant or adjuvant setting and completed more than 12 month before registration) 8) Required baseline laboratory parameters before registers: WBC : >= 3,000mm3 or neutrophil : >= 1,500mm3 Plt : >= 75,000mm3 Hb : >= 9.0g/dl AST <= 2.5 times ULN and ALT <= 2.5 times ULN (<=5.0 with liver metastasis) Serum creatinine <= ULN Normal EOG 9) Signed informed consent of the patient for the registration

Exclusion criteria

Exclusion criteria: 1) Previously treated with bevacizumab 2) Primary chemotherapy refractory with Paclitaxel 3) The operation has been scheduled for the examination period 4) Uncontrollable hypertension 5) Symptomatic brain metastasis 6) Anaphylaxis against drugs used in protocol treatment 7) Uncontrollable ascites, pleural effusion 8) Active infection, Severe complications (abnormal electrocardiogram, heart failure, arrhythmia, thromboembolism, etc) 9) Severe infection or serious complications, such as hypoalimentation 10) Other active malignancies 11) Pregnant or nursing women or women who like be pregnant and men with partner willing to get pregnant 12) Doctors decision for exclusion

Design outcomes

Primary

Measure	Time frame
Overall response rate	—

Secondary

Measure	Time frame
Clinical benefit rate, Progression-free survival, Safety	—

Countries

Japan

Contacts

Public ContactMasahiro Kishimoto

Meiwa Hospital Department of breast and endocrine surgery

mm-kishi@hotmail.co.jp0798-47-1767

Outcome results

None listed

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