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A multicentre randomised study of dose-intensive chemotherapy as primary treatment in a multimodality approach for locally advanced or inflammatory breast cancer

Completed
Conditions
Breast cancer
Cancer
Malignant neoplasm of breast
Registration Number
ISRCTN78982321
Lead Sponsor
European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Female
Target Recruitment
400
Inclusion Criteria

1. Female patients with histologically confirmed breast cancer in the following subgroups:
1.1. T4 Nx
1.2. Any N2 or N3, M0
1.3. Clinically inflammatory breast carcinoma defined as redness over at least one-third of the breast
1.4. M0 except for ipsilateral supraclavicular nodes
2. No evidence of tumour spread other than as defined above
3. No previous surgical, systemic or radiation treatment for breast cancer, other than biopsy for confirmation of the diagnosis
4. World Health Organisation (WHO) performance status zero to two
5. Adequate renal, hepatic and haematological function
6. No previous or concomitant malignancy except adequately treated squamous or basal cell carcinoma of the skin, or adequately treated cone-biopsied in situ carcinoma of the cervix uteri
7. No significant cardiac disease

Exclusion Criteria

Does not match inlcusion criteria

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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