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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN78982321
Enrollment
400
Registered
2002-08-19
Start date
1996-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer Cancer Malignant neoplasm of breast

Interventions

1. Regimen A: Chemotherapy with cyclophosphamide, epirubicin and 5-fluorouracil (CEF) repeated every four weeks for six courses, unless there is earlier progression, plus oral trimethoprim-sulphametho

Sponsors

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

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria: Does not match inlcusion criteria

Design outcomes

Primary

MeasureTime frame
Added 06/08/09: 1. Response rate 2. Survival 3. Quality of life

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026