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

Phase 3

Completed

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

• Registration Number: ISRCTN58579496
• Lead Sponsor: European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2006-11-06
• Study Start: 2010-05-19
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1850

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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<br>2. Survival, calculated from date of randomisation to date of death<br>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<br>4. Toxicity, measured according to Common Toxicity Criteria (CTC) scale version 2.0