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Completed

NCT Number: NCT00288249

Safety and Efficacy Study of a New Chemotherapy Agent to Treat Metastatic Breast Cancer

The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with metastatic breast cancer

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Key information

Conditions

Breast Neoplasms Breast Cancer, Metastatic Breast Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Vienna, State of Vienna, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Sagopilone (BAY86-5302, ZK 219477)

Drug

16 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.

Primary outcomes

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

    Time frame: Every 6 weeks

    The proportion of subjects with either complete or partial response according to the modified RECIST criteria was calculated as best overall response after 6 courses of therapy (i.e., before Course 7).

Secondary outcomes

  1. Duration of complete or partial tumor response

    Time frame: Every 6 weeks

    Defined as the time between the first date that confirmed complete or partial response was established as "overall response" and the first date that recurrence or overall response of progressive disease was documented

  2. Time to tumor progression

    Time frame: Every 6 weeks

    Defined as the time from the start of study treatment to the first objective evidence of tumor progression, symptomatic deterioration, or death from cancer

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Feb 7, 2006
Registry last updated
Dec 2, 2014

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.

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