NCT00467012

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2007

Typical duration for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

April 26, 2012

Status Verified

April 1, 2012

Enrollment Period

2.2 years

First QC Date

April 26, 2007

Last Update Submit

April 25, 2012

Conditions

Metastatic Breast Cancer

Keywords

Inoperable metastatic breast cancer

Outcome Measures

Primary Outcomes (2)

  • Safety

    throughout study

  • Progression-free survival (PFS)

    event driven

Secondary Outcomes (3)

  • Overall Survival(OS)

    event driven

  • Time to Treatment Failure(TTF)

    evnt driven

  • Response Rate(RR)

    event driven

Study Arms (2)

step 1

EXPERIMENTAL

6 enrollment for 1 cycle(4 weeks)

Drug: bevacizumabDrug: Paclitaxel

step 2

EXPERIMENTAL

114 enrollment through to meet the stopping criteria

Drug: bevacizumabDrug: Paclitaxel

Interventions

bevacizumabDRUG

10mg/kg，Day1, 15 of 1 cycle(4 weeks)

step 1step 2
PaclitaxelDRUG

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

step 1step 2

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (5)

Kanto Region

Kanto, Japan

Location

Kinki Region

Kinki, Japan

Location

Kyushu region

Kyushu, Japan

Location

Sikoku region

Sikoku, Japan

Location

Tohoku region

Tōhoku, Japan

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

BevacizumabPaclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Shingo Koganezawa

    Clinical research department 3

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2007

First Posted

April 27, 2007

Study Start

April 1, 2007

Primary Completion

June 1, 2009

Study Completion

September 1, 2011

Last Updated

April 26, 2012

Record last verified: 2012-04

Locations

JP(5)