Primary breast cancer Cancer Malignant neoplasm of the breast
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women aged 18 - 70 years 2. Unilateral/bilateral large (greater than or equal to 3 cm) or locally advanced primary breast cancer (T3, T4, TxN2), no distant metastases 3. World Health Organization (WHO) performance status of less than 2 4. Adequate cardiac, haematological, renal, and hepatic function
Exclusion criteria
Exclusion criteria: 1. Pregnant 2. Previous malignancy (except curatively treated carcinoma in situ of the cervix or basal cell carcinoma of skin) 3. Previous cytotoxic, endocrine, or radiotherapy 4. Active infection 5. Contraindications to corticosteroid administration 6. Pre-existing neurotoxicity (greater than grade 2) as defined by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) 7. Significant cognitive impairment or dementia 8. Inability to complete quality of life (QoL) questionnaires or provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life 3 weeks after completion of chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical and pathological responses at 12 weeks 2. Disease free survival and overall survival at 5 years | — |
Countries
United Kingdom