Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr M Verrill
ORCID ID
Contact details
University of Newcastle Department of Oncology
Newcastle General Hospital
Westgate Road
Newcastle Upon Tyne
NE4 6BE
United Kingdom
+44 (0)191 219 4252
mark.verrill@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BR0201
Study information
Scientific title
A randomised two-arm, prospective, multi-centre, open-label phase III trial comparing the activity and safety of a weekly versus a three-weekly paclitaxel treatment schedule in patients with advanced or metastatic breast cancer
Acronym
Study hypothesis
Primary objectives:
1. To compare the antitumour efficacy of weekly versus three-weekly paclitaxel as determined by the time to disease progression
2. To study polymorphisms in the genes responsible for paclitaxel metabolism and link these to response rates and toxicity
Secondary objectives:
1. To compare the toxicity of weekly versus three-weekly paclitaxel
2. To compare the response rate of weekly versus three-weekly paclitaxel
3. To compare overall survival in patients receiving weekly versus three-weekly paclitaxel
4. To compare quality of life in patients receiving weekly versus three-weekly paclitaxel
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Breast cancer
Intervention
Arm 1: Paclitaxel (90 mg/m^2 intravenous [IV] over 1 hour on day 1 every week for 12 cycles)
Arm 2: Paclitaxel (175 mg/m^2 IV over 3 hours on day 1 every 3 weeks for 6 cycles)
Intervention type
Drug
Phase
Phase III
Drug names
Paclitaxel
Primary outcome measures
1. Antitumour efficacy, as determined by the time to disease progression
2. Polymorphisms in the genes responsible for paclitaxel metabolism, response rates and toxicity
Secondary outcome measures
1. Toxicity
2. Response rate
3. Overall survival
4. Quality of life
Overall trial start date
16/09/2002
Overall trial end date
01/01/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Histologically proven breast cancer
2. Locally advanced or metastatic disease
3. Presence of measurable or evaluable lesions
4. Prior treatment with anthracyclines (either in the adjuvant setting or for metastatic disease) or contraindication to anthracyclines
5. Aged 18 years or greater
6. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
7. Adequate haematological, renal and hepatic function
8. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
600
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
16/09/2002
Recruitment end date
01/01/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Newcastle Department of Oncology
Newcastle Upon Tyne
NE4 6BE
United Kingdom
Sponsor information
Organisation
Anglo Celtic Cooperative Oncology Group (UK)
Sponsor details
SCTN Central Office
Information & Statistics Division
Trinity Park House
South Trinity Road
Edinburgh
EH5 3SQ
United Kingdom
+44 (0)131 551 8363
joanna.dunlop@isd.csa.scot.nhs.uk
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Anglo Celtic Cooperative Oncology Group (UK) - supported by an educational grant from Bristol-Myers Squibb Pharmaceuticals Limited
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary