Breast Cancer Cancer Breast cancer
Conditions
Interventions
Arm A: fluorouracil (5 FU) 600 mg/m2, epirubicin 75 mg/m2 and cyclophosphamide 600 mg/m2
six cycles every 21 days
Arm B: letrozole 2.5 mg po per day for 21 weeks
Sponsors
Imperial College London (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Histologically proven primary breast cancer which is thought to require mastectomy and where it is felt that cytoreductive systemic therapy would enable conservative surgery to be performed. 2. Postmenopausal up to the age of 75 years of age 3. Estrogen-receptor positive 4. Pre-treatment haematology and biochemistry values within acceptable limits 5. World Health Organisation (WHO) performance status zero or one 6. Primary breast tumour amenable to biopsy 7. Consent to having a repeat biopsy of breast tumour 8. Written informed consent prior to commencement of specific protocol procedures
Exclusion criteria
Exclusion criteria: 1. Indicated for urgent neoadjuvant therapy, i.e., inflammatory or near ulcerating breast cancer 2. Bilateral invasive breast cancer 3. Any prior chemotherapy, hormone therapy or radiation for breast cancer 4. Evidence of distant metastatic disease as disclosed by bone scan, liver ultrasound scan and chest radiology 5. Past or current history of neoplasm other than breast carcinoma, except for: a. curatively treated non-melanoma skin cancer b. in situ carcinoma of the cervix c. other cancer curatively treated and with no evidence of disease for at least ten years d. ipsilateral Ductal Carcinoma In-Situ (DCIS) of the breast e. Lobular Carcinoma In-Situ (LCIS) of the breast 6. Other serious illness or medical condition: a. congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within one year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias b. history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent c. active uncontrolled infection d. active peptic ulcer, unstable diabetes mellitus 7. In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease such as unstable hypertension, respiratory, cardiac, hepatic, and renal disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical response rates | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Radiological response rates using breast ultrasound and mammogram 2. To compare the rates of conservation surgery 3. To compare degree of pathological response 4. To compare Ki-67 protein changes and its relationship to treatment response 5. To investigate the roles of members of the forkhead family in mediating endocrine and chemotherapy-induced regression 6. To evaluate the length of time to maximum response within the treatment period 7. To compare effects on markers of apoptosis and the cell cycle 8. To compare tolerability of the various treatments 9. To compare quality of life (QoL) of the various treatments | — |
Countries
United Kingdom
Outcome results
None listed