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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ISRCTN
Last refreshed on:	12 November 2018
Main ID:	ISRCTN58579496
Date of registration:	19/05/2010
Prospective Registration:	No
Primary sponsor:	European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)
Public title:	First prospective Intergroup Translational Research Trial of the potential predictive value of p53 in patients with locally advanced/inflammatory or large operable breast cancer
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
Date of first enrolment:	25/04/2001
Target sample size:	1850
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN58579496
Study type:	Interventional
Study design:	Multicentre randomised interventional treatment trial (Treatment)
Phase:	Phase III

Countries of recruitment
United Kingdom

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Kirsten Murray
Address:	Area 159C, 1st Floor Gyle Square 1 South Gyle Crescent EH12 9EB Edinburgh United Kingdom
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

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)
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

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast
Cancer
Breast cancer

Intervention(s)

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

Primary Outcome(s)

Progression free survival, calculated from date of randomisation to the first evidence of progression or recurrence or death, whichever occurs first

Secondary Outcome(s)

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

Secondary ID(s)

827

Source(s) of Monetary Support

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

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Multicentre Research Ethics Committee for Scotland, 11/12/2001, ref: MREC/01/0/22

Results

Results available:	Yes
Date Posted:
Date Completed:	06/11/2006
URL:

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