Condition category
Cancer
Date applied
15/10/2002
Date assigned
15/10/2002
Last edited
11/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.amgen.com

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

Publication citations

Additional files

Editorial Notes

11/01/2016: no publications found on PubMed.