check_circleStudy Completed

Breast Neoplasms, Breast Cancer

BAY43-9006 - Phase II in Advanced Breast Cancer

Trial purpose

The purpose of this study is to evaluate the anti-cancer activity and safety of BAY43-9006 (Sorafenib) in patients, who suffer from an advanced breast tumour, which has spread to other organs of body despite treatment that the patient has received so far.

Key Participants Requirements

Sex

Female

Age

18 Years

Trial summary

Enrollment Goal
54
Trial Dates
February 2004 - January 2008
Phase
Phase 2
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Frauenklinik vom Roten KreuzMünchen, 80637, Germany
Completed
IRCCS Istituto Nazionale TumoriMilano, 20133, Italy
Completed
Klinikum der Johann Wolfgang Goethe Universität FrankfurtFrankfurt, 60590, Germany
Completed
A.O. Osp Niguarda Ca' GrandaMilano, 20162, Italy
Completed
MarienhospitalStuttgart, 70199, Germany
Completed
A.O.U. di BolognaBologna, 40138, Italy
Completed
A.O.U. di ParmaParma, 43100, Italy

Primary Outcome

  • Number of Subjects With Response (Complete or Partial)
    date_rangeTime Frame:
    Until 30 days after termination of active therapy
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Time to Progression
    date_rangeTime Frame:
    Until progression occurs
    enhanced_encryption
    Safety Issue:
    No
  • Time to Objective Response
    date_rangeTime Frame:
    Until objective response occurs
    enhanced_encryption
    Safety Issue:
    No
  • Overall Response Duration
    date_rangeTime Frame:
    Time from PR or CR to progression
    enhanced_encryption
    Safety Issue:
    No
  • Survival Time
    date_rangeTime Frame:
    Start of treatment to death
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects With Stable Disease up to Cycle 4
    date_rangeTime Frame:
    Until 30 days after termination of active therapy
    enhanced_encryption
    Safety Issue:
    No

Trial design

A phase II multicenter uncontrolled trial of BAY43-9006 in subjects with metastatic breast cancer.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1