First prospective Intergroup Translational Research Trial of the potential predictive value of p53 in patients with locally advanced/inflammatory or large operable breast cancer

ISRCTN	ISRCTN58579496
DOI	https://doi.org/10.1186/ISRCTN58579496
Secondary identifying numbers	827

Submission date: 19/05/2010
Registration date: 19/05/2010
Last edited: 19/10/2018

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-to-see-if-p53-gene-damage-can-predict-how-well-different-chemotherapy-drugs-will-work-for-breast-cancer

Contact information

Miss Kirsten Murray
Scientific

Area 159C, 1st Floor
Gyle Square
1 South Gyle Crescent
Edinburgh
EH12 9EB
United Kingdom

Study information

Study design	Multicentre randomised interventional treatment 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	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
Study acronym	p53 Study
Study objectives	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(s)	Multicentre Research Ethics Committee for Scotland, 11/12/2001, ref: MREC/01/0/22
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	5-FU, docetaxel, epirubicin
Primary outcome measure	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 study start date	25/04/2001
Completion date	06/11/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Planned sample size: 1850
Key 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)
Key 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
Date of first enrolment	25/04/2001
Date of final enrolment	06/11/2006

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Area 159C, 1st Floor

Edinburgh
EH12 9EB
United Kingdom

Sponsor information

European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)
Research organisation

Avenue Mounierlaan, 83/11
Brussels
1200
Belgium

Website	http://www.eortc.be/
"ROR"	https://ror.org/034wxcc35

Funders

Funder type

Research organisation

European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)

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

19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
11/04/2017: No publications found in PubMed, verifying study status with principal investigator