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Prospective, Multicenter, Randomized, Independent-group, Open-label Phase II Study to Investigate the Efficacy, Safety and Tolerability of 4 Regimen With 3 Doses of ZK 219477 (16 and 12 mg/m2 Body Surface Area as 3-hour Infusion or 22 mg/m2 Body Surface Area as 30-minute or 3-hour Infusion) in Patients With Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms, Breast Cancer, Metastatic

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Trial Information

Prospective, Multicenter, Randomized, Independent-group, Open-label Phase II Study to Investigate the Efficacy, Safety and Tolerability of 4 Regimen With 3 Doses of ZK 219477 (16 and 12 mg/m2 Body Surface Area as 3-hour Infusion or 22 mg/m2 Body Surface Area as 30-minute or 3-hour Infusion) in Patients With Metastatic Breast Cancer


The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the
sponsor of the trial.


Inclusion Criteria:



- Metastatic breast cancer

- No previous treatment with taxanes, and vinca alkaloids

- Use of highly effective birth control methods in females of child-bearing potential

Exclusion Criteria:

- More than 2 previous chemotherapies

- Previous participation in another trial within the last 4 weeks

- Breast feeding

- Active infections

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response rate (complete or partial response according to RECIST)

Outcome Time Frame:

Every 8 weeks

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Austria: Federal Ministry for Health and Women

Study ID:

91464

NCT ID:

NCT00288249

Start Date:

December 2005

Completion Date:

January 2009

Related Keywords:

  • Breast Neoplasms
  • Breast Cancer, Metastatic
  • Breast Cancer
  • Breast Neoplasms
  • Breast Neoplasms
  • Neoplasms

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