check_circleStudy Completed

Breast Neoplasms, Breast Cancer, Metastatic

Bayer Identifier:

91464

ClinicalTrials.gov Identifier:

NCT00288249

EudraCT Number:

2005-003216-30

EU CT Number:

Not Available
Safety and efficacy study of a new chemotherapy agent to treat metastatic breast cancer

Trial purpose

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

Key Participants Requirements

Sex

Female

Age

18 - N/A
  • - Metastatic breast cancer
    - No previous treatment with taxanes, and vinca alkaloids
    - Use of highly effective birth control methods in females of child-bearing potential
  • - More than 2 previous chemotherapies
    - Previous participation in another trial within the last 4 weeks
    - Breast feeding
    - Active infections

Trial summary

Enrollment Goal
82
Trial Dates
December 2005 - January 2009
Phase
Phase 2
Could I Receive a placebo
No
Products
Sagopilone (BAY86-5302)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Allgemeines Krankenhaus der Stadt Wien UniversitätsklinikenWien, 1090, Austria
Completed
Centre Paul PapinAngers, 49033, France
Completed
Centre Jean Perrin Clermont FerrandClermont Ferrand, 63011, France
Completed
Klinicni centerLjubljana, 1000, Slovenia
Completed
Christie HospitalManchester, M20 4BX, United Kingdom
Completed
SMZ Süd- Kaiser- Franz- Josef- SpitalWien, 1100, Austria
Completed
District Dispensary for Oncology Diseases with InpatientSofia, 01784, Bulgaria
Completed
Dr. Antoaneta TomovaPlovdiv, 4001, Bulgaria
Completed
Oncology Dispencery VarnaVarna, 9000, Bulgaria
Completed
Centre GauducheauSaint Herblain Cedex, 44805, France
Completed
Institut BergonieBordeaux, 33076, France
Completed
Centre Alexis VautrinVandoeuvre les Nancy, 54500, France
Completed
Universitätsklinikum Charite zu BerlinBerlin, 10117, Germany
Completed
P.O. Morgagni-PierantoniForlì, 47100, Italy
Completed
A.O. S.Maria NuovaReggio Emilia, 42100, Italy
Completed
Ospedale Niguarda Ca' GrandaMilano, 20162, Italy
Completed
Hospital Clínico Universitario San CarlosMadrid, 28040, Spain
Completed
Hospital Virgen de la VictoriaMálaga, 29010, Spain
Completed
AZ KlinaBRASSCHAAT, 2930, Belgium
Completed
Centrum Onkologii - Instytut im. M.Sklodowskiej-CurieWarszawa, 02-781, Poland
Completed
ZOZ MSWiA z Warminsko-Mazurskim Centrum OnkologiiOlsztyn, 10-228, Poland

Primary Outcome

  • Tumor response rate (complete or partial response according to RECIST)
    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).
    date_rangeTime Frame:
    Every 6 weeks
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Duration of complete or partial tumor response
    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
    date_rangeTime Frame:
    Every 6 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Time to tumor progression
    Defined as the time from the start of study treatment to the first objective evidence of tumor progression, symptomatic deterioration, or death from cancer
    date_rangeTime Frame:
    Every 6 weeks
    enhanced_encryption
    Safety Issue:
    no

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
4

Additional Information

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