Phase Ⅱ Clinical Study of R435 (Bevacizumab) in Combination With Paclitaxel in Patients With Inoperable Metastatic Breast Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00467012

Enrollment

122

Registered

2007-04-27

Start date

2007-04-30

Completion date

2011-09-30

Last updated

2012-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer

Keywords

Inoperable metastatic breast cancer

Brief summary

To investigate the efficacy, safety, and pharmacokinetics when R435 and paclitaxel are administered concomitantly to patients with metastatic breast cancer.

Interventions

DRUGbevacizumab

10mg/kg，Day1, 15 of 1 cycle(4 weeks)

DRUGPaclitaxel

90mg/ m2，Day1, 8, 15 of 1 cycle(4 weeks)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* At least 20 years old and obtained a written informed consent * Advanced breast cancer (StageⅣ) or Inoperable metastatic breast cancer * HER2 negative * At least one measurable lesion based on RECIST criteria * No previous chemotherapy for metastatic breast cancer

Design outcomes

Primary

Measure	Time frame
Safety	throughout study
Progression-free survival (PFS)	event driven

Secondary

Measure	Time frame
Time to Treatment Failure(TTF)	evnt driven
Response Rate(RR)	event driven
Overall Survival(OS)	event driven

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026