Condition category
Cancer
Date applied
19/05/2010
Date assigned
19/05/2010
Last edited
14/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Miss Kirsten Murray

ORCID ID

Contact details

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

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 approved on the 11th December 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

http://www.eortc.be/

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

Publication citations

Additional files

Editorial Notes