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

ISRCTN	ISRCTN52817670
DOI	https://doi.org/10.1186/ISRCTN52817670
Secondary identifying numbers	BR0201

Submission date: 15/10/2002
Registration date: 15/10/2002
Last edited: 07/10/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-weekly-versus-3-weekly-paclitaxel-for-breast-cancer-that-has-spread

Contact information

Dr M Verrill
Scientific

University of Newcastle Department of Oncology
Newcastle General Hospital
Westgate Road
Newcastle Upon Tyne
NE4 6BE
United Kingdom

Phone	+44 (0)191 219 4252
Email	mark.verrill@ncl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Paclitaxel
Primary outcome measure	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 study start date	16/09/2002
Completion date	01/01/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	600
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	16/09/2002
Date of final enrolment	01/01/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Newcastle Department of Oncology

Newcastle Upon Tyne
NE4 6BE
United Kingdom

Sponsor information

Anglo Celtic Cooperative Oncology Group (UK)
Research organisation

SCTN Central Office
Information & Statistics Division
Trinity Park House
South Trinity Road
Edinburgh
EH5 3SQ
United Kingdom

Phone	+44 (0)131 551 8363
Email	joanna.dunlop@isd.csa.scot.nhs.uk
Website	http://www.amgen.com

Funders

Funder type

Research organisation

Anglo Celtic Cooperative Oncology Group (UK) - supported by an educational grant from Bristol-Myers Squibb Pharmaceuticals Limited

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes

Editorial Notes

07/10/2020: Cancer Research UK lay results summary link added to Results (plain English).
11/01/2016: no publications found on PubMed.
27/02/2018: No publications found, verifying study status with principal investigator.