Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
827
Study information
Scientific title
First prospective Intergroup Translational Research Trial assessing the potential predictive value of p53 using a functional assay in yeast in patients with locally advanced/inflammatory or large operable breast cancer prospectively randomised to a taxane versus a non taxane regimen
Acronym
p53 Study
Study hypothesis
The study had two main objectives:
1. Test a treatment effect by comparing an anthracycline based regime (standard treatment) to a taxane plus anthracycline regimen ("new" treatment) separately in the normal and mutated p53 subgroups, p53 being assessed by a functional assay in yeast
2. Test an interaction effect between p53 status and the chemotherapy regimen (with or without taxanes)
Ethics approval
Multicentre Research Ethics Committee for Scotland, 11/12/2001, ref: MREC/01/0/22
Study design
Multicentre randomised interventional treatment 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
Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast
Intervention
1. Non-taxane arm: either FEC100 (epirubicin 100 mg/m2 with 5-fluorouracil 500 mg/m2 and cyclophosphamide 500 mg/m2) every 3 weeks for 6 cycles or Canadian FEC (oral cyclophosphamide on days 1-14 and epirubicin IV and fluorouracil IV on days 1 and 8) every 4 weeks for 6 cycles or tailored FEC (fluorouracil IV over 15 minutes, epirubicin IV over 1 hour, and cyclophosphamide IV over 1-2 hours on day 1; patients also receive filgrastim (G-CSF) subcutaneously on days 2-15 or until blood counts recover) x 6 (every 3 weeks for 6 cycles)
2. Taxane arm: 3 cycles Docetaxel (every 3 weeks for 3 cycles) followed by 3 cycles Epirubicin/Docetaxel (every 3 weeks for 3 cycles)
Follow up for both arms is till death
Study entry: single randomisation only
Intervention type
Drug
Phase
Phase III
Drug names
5-FU, docetaxel, epirubicin
Primary outcome measures
Progression free survival, calculated from date of randomisation to the first evidence of progression or recurrence or death, whichever occurs first
Secondary outcome measures
1. Distant metastasis free survival, calculated from the date of randomisation to the first evidence of recurrent disease outside radiation field or death, whichever occurs first
2. Survival, calculated from date of randomisation to date of death
3. Clinical and pathological responses, assessed after 3rd cycle and at the end of neoadjuvant chemotherapy according to Response Evaulation Criteria in Solid Tumours (RECIST) criteria for tumour progression
4. Toxicity, measured according to Common Toxicity Criteria (CTC) scale version 2.0
Overall trial start date
25/04/2001
Overall trial end date
06/11/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Histologically confirmed breast cancer: Locally advanced or inflammatory disease:
1.1. + T4a-d, any N, M0, or
1.2. + Any T, N2 or N3, M0
1.3. + Large T2 or T3 breast cancer requiring tumor shrinkage prior to breast conservation surgery
2. Frozen tumor sample available:
2.1. One incisional biopsy, or
2.2. Two trucut biopsies from a 14G needle
3. No prior chemotherapy
4. No prior radiotherapy
5. Age: 70 and under
6. Female
7. Performance status: World Health Organization (WHO) 0 - 1
8. Neutrophil count greater than 1,500/mm^3
9. Platelet count greater than 100,000/mm^3
10. Bilirubin less than 1.2 mg/dL
11. Serum glutamic oxaloacetic transaminase (SGOT) less than 60 IU/L
12. Creatinine less than 1.35 mg/dL
13. Left ventricular ejection fraction (LVEF) normal by echocardiography or multiple gated acquisition scan (MUGA)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Planned sample size: 1850
Participant exclusion criteria
1. No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
2. No serious uncontrolled medical condition
3. No uncontrolled psychiatric or addictive disorders
4. Not pregnant or nursing
5. Fertile patients must use effective contraception
Recruitment start date
25/04/2001
Recruitment end date
06/11/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Area 159C, 1st Floor
Edinburgh
EH12 9EB
United Kingdom
Sponsor information
Organisation
European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)
Sponsor details
Avenue Mounierlaan
83/11
Brussels
1200
Belgium
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)
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