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 |
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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
Contact information
Miss Kirsten Murray
Scientific
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 |
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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 |
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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
EH12 9EB
United Kingdom
Sponsor information
European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)
Research organisation
Research organisation
Avenue Mounierlaan, 83/11
Brussels
1200
Belgium
Website | http://www.eortc.be/ |
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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 | |
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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? |
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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