Trial Condition(s):
Breast Neoplasms, Breast Cancer, Metastatic
Safety and efficacy study of a new chemotherapy agent to treat metastatic breast cancer
Bayer Identifier:
91464
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Allgemeines Krankenhaus der Stadt Wien Universitätskliniken Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Paul Papin Angers, France, 49033 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Jean Perrin Clermont Ferrand Clermont Ferrand, France, 63011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinicni center Ljubljana, Slovenia, 1000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Christie Hospital Manchester, United Kingdom, M20 4BX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SMZ Süd- Kaiser- Franz- Josef- Spital Wien, Austria, 1100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations District Dispensary for Oncology Diseases with Inpatient Sofia, Bulgaria, 01784 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Antoaneta Tomova Plovdiv, Bulgaria, 4001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oncology Dispencery Varna Varna, Bulgaria, 9000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Gauducheau Saint Herblain Cedex, France, 44805 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institut Bergonie Bordeaux, France, 33076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Alexis Vautrin Vandoeuvre les Nancy, France, 54500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Charite zu Berlin Berlin, Germany, 10117 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations P.O. Morgagni-Pierantoni Forlì, Italy, 47100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. S.Maria Nuova Reggio Emilia, Italy, 42100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ospedale Niguarda Ca' Granda Milano, Italy, 20162 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario San Carlos Madrid, Spain, 28040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Virgen de la Victoria Málaga, Spain, 29010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AZ Klina BRASSCHAAT, Belgium, 2930 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centrum Onkologii - Instytut im. M.Sklodowskiej-Curie Warszawa, Poland, 02-781 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii Olsztyn, Poland, 10-228 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
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).Timeframe: Every 6 weeks
Secondary Outcome
- Duration of complete or partial tumor responseDefined 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 documentedTimeframe: Every 6 weeks
- Time to tumor progressionDefined as the time from the start of study treatment to the first objective evidence of tumor progression, symptomatic deterioration, or death from cancerTimeframe: Every 6 weeks
Additional Information
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