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CompletedNCT00313248Updated Dec 10, 2015

Evaluation of a New Agent for Treatment of Advanced Stage Breast Cancer

A Phase 2 interventional study of Sagopilone (ZK 219477) and Sagopilone (ZK 219477) in Breast Neoplasm, sponsored by Bayer. Completed at 25 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-10.

Sponsored by Bayer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
65
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
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Study summary

The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) in patients with metastatic breast cancer helps to decrease or stop tumor growth.

Read the detailed description

This study has previously been registered by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of this study.

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Conditions studied

  • Breast Neoplasm

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Keywords

  • Breast Cancer
  • 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 65 is close to the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

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

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Who can participate

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

Inclusion criteria

  • Metastatic breast cancer (meaning the cancer has spread beyond its original location)
  • At least one measurable lesion by CT or MRI
  • Progression of disease following previous therapy for breast cancer
  • Have received previous treatment with anthracyclines (e.g. doxorubicin[Adriamycin or Doxil] or epirubicin [Ellence]), taxanes (paclitaxel [Taxol or Abraxane] or docetaxel [taxotere]) for your breast cancer
  • Not be pregnant
  • Additional criteria to be determined at screening visit.

Exclusion criteria

Exclusion Criteria:

  • More than 3 previous chemotherapy regimens
  • More than one treatment with non cytotoxic agents for breast cancer therapy (e.g. herceptin [trastuzumab] or Avastin [bevacizumab)
  • Prior treatment with epothilones (e.g. Ixabepilone)
  • Symptomatic brain metastases
  • Additional criteria to be determined at screening visit
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Study design

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

Study arms

  • Experimental
    Arm 1

    Drug: Sagopilone (ZK 219477)

  • Experimental
    Arm 2

    Drug: Sagopilone (ZK 219477)

Interventions

  • DrugSagopilone (ZK 219477)

    All patients will receive ZK-Epo at a dose of 16mg/m2 as an intravenous infusion. Chemotherapy for recurrent breast cancer.

    Also known as: BAY86-5302

  • DrugSagopilone (ZK 219477)

    Patients will receive 22mg/m2 as intravenous infusion.

    Also known as: BAY86-5302

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What researchers measure

Primary outcomes

  1. Response to treatment with ZK-Epo after 6 cycles

    Time frame: complete or partial response after 2 to 6 courses of therapy.

Secondary outcomes

  1. Safety and tolerability of ZK-Epo

    Time frame: time to progression after start of study treatment and response duration from time between first date of confirmed PR or CR.

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Study locations

25 sites
  • Birmingham, Alabama 35233, United States
  • Anchorage, Alaska 99508, United States
  • Tucson, Arizona 85724, United States
  • Hot Springs, Arkansas 71913, United States
  • Bakersfield, California 93309, United States
  • Palm Springs, California 92262, United States
  • Aurora, Colorado 80010, United States
  • Washington, District of Columbia 20007, United States
  • Daytona Beach, Florida 32114, United States
  • Decatur, Illinois 62526, United States
  • New Albany, Indiana 47150, United States
  • Baltimore, Maryland 21204, United States
  • Minneapolis, Minnesota 55455, United States
  • Livingston, New Jersey 07039, United States
  • New York, New York 10021, United States
  • Syracuse, New York 13210, United States
  • Portland, Oregon 97239, United States
  • Pittsburgh, Pennsylvania 15213-3180, United States
  • Houston, Texas 77030, United States
  • San Antonio, Texas 78207, United States
  • Tacoma, Washington 98405, United States
  • Toronto, Ontario M4N 3M5, Canada
  • Greenfield Park, Quebec J4V 2H1, Canada
  • Montreal, Quebec H3T 1E2, Canada
  • Quebec, G1S 4L8, Canada
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References and documents

Publications

  • Morrow PK, Divers S, Provencher L, Luoh SW, Petrella TM, Giurescu M, Schmelter T, Wang Y, Hortobagyi GN, Vahdat LT. Phase II study evaluating the efficacy and safety of sagopilone (ZK-EPO) in patients with metastatic breast cancer that has progressed following chemotherapy. Breast Cancer Res Treat. 2010 Oct;123(3):837-42. doi: 10.1007/s10549-010-1102-x. Epub 2010 Aug 10. PubMed 20697802 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00313248
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Apr 12, 2006
Start date
Apr 2006
Primary completion
Oct 2008
Completion
Nov 2008
Last update
Dec 10, 2015

Study contacts

Bayer Study Director
study director · Bayer

Oversight

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

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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