Skip to main content
OpenTrials
Completed

NCT Number: NCT00467012

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Kanto Region, Kanto, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Bevacizumab

Drug

10mg/kg，Day1, 15 of 1 cycle(4 weeks)

paclitaxel

Drug

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

Primary outcomes

  1. Safety

    Time frame: throughout study

  2. Progression-free survival (PFS)

    Time frame: event driven

Secondary outcomes

  1. Overall Survival(OS)

    Time frame: event driven

  2. Time to Treatment Failure(TTF)

    Time frame: evnt driven

  3. Response Rate(RR)

    Time frame: event driven

Sponsors and collaborators

Lead sponsor

Chugai Pharmaceutical

Industry

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2011
First posted
Apr 27, 2007
Registry last updated
Apr 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.