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CompletedNCT00467012Updated Apr 26, 2012

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

A Phase 2 interventional study of bevacizumab and Paclitaxel in Metastatic Breast Cancer, sponsored by Chugai Pharmaceutical. Completed at 5 sites in Japan. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2012-04-26.

Sponsored by Chugai Pharmaceutical · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
122
Allocation
Non-randomized
Ages
20 Years and older
Sex
Female
01

Study summary

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

02

Conditions studied

  • Metastatic Breast Cancer

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Keywords

  • Inoperable metastatic breast cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 122 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Chugai Pharmaceutical is the lead sponsor of 63 studies on the registry; 7 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
122 participants (actual)

Study arms

  • Experimental
    step 1

    6 enrollment for 1 cycle(4 weeks)

    Drug: bevacizumab · Drug: Paclitaxel

  • Experimental
    step 2

    114 enrollment through to meet the stopping criteria

    Drug: bevacizumab · Drug: Paclitaxel

Interventions

  • Drugbevacizumab

    10mg/kg，Day1, 15 of 1 cycle(4 weeks)

  • DrugPaclitaxel

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

06

What researchers measure

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

07

Study locations

5 sites
  • Kanto Region
    Kanto, Japan
  • Kinki Region
    Kinki, Japan
  • Kyushu region
    Kyushu, Japan
  • Sikoku region
    Sikoku, Japan
  • Tohoku region
    Tohoku, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00467012
Lead sponsor
Chugai Pharmaceutical
Responsible party
Sponsor
First posted
Apr 27, 2007
Start date
Apr 2007
Primary completion
Jun 2009
Completion
Sep 2011
Last update
Apr 26, 2012

Study contacts

Shingo Koganezawa
study chair · Clinical research department 3

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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