Early invasive unilateral breast cancer larger than 2 cm in diameter Cancer Malignant neoplasm of breast
Conditions
Interventions
1. Patients in Study 1 will randomly receive one of the three following regimens
1.1. AT: doxorubicin (60 mg/ m^2) plus paclitaxel (200 mg/m^2) every 3 weeks for 4 cycles sequentially followed by CMF:
Sponsors
Fondazione Michelangelo (Italy)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female patients, presenting for the first time with unilateral operable breast cancer larger than 2.0 cm in largest diameter, who have not received any previous treatment for an invasive malignancy 2. Histologically proven diagnosis of invasive breast cancer 3. Estrogen receptor status assessed as negative (Study 1) or positive (Study 2) 4. Age greater than or equal to 18 years 5. Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 1 6. Availability of Human EGF (Epidermal Growth Factor) Receptor 2 (HER2) status on immunohistochemistry 7. Availability of progesterone receptor status 8. Primary tumour lesion measurable on largest diameter by clinical and/or radiological examination. Presence of suspected multifocal disease does not exclude the patient 9. Patients must have completed all instrumental and laboratory evaluations within 4 weeks prior to study entry 10. Signed written informed consent (approved by the Institutional Review Board [IRB]/ Independent Ethics Committee [IEC]) obtained prior to any study specific screening procedures 11. Able to comply with the protocol
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women. Documentation of a negative pregnancy test must be available for premenopausal women with intact reproductive organs and for women less than one year after the menopause 2. Women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception. For example: intra-uterine device or barrier method of contraception in conjunction with spermicidal jelly 3. Evidence of metastases or locally advanced breast cancer 4. Bilateral breast cancer 5. Absence of ER assessment 6. Previous treatment with chemotherapy or hormonal therapy or any prior therapy with any investigational drug for any type of malignancy 7. Previous extensive radiotherapy or major surgery for any malignancy 8. Previous or concomitant malignancy of any type, except adequately treated basal cell carcinoma of the skin or in situ cervix cancer 9. Patients with New York Heart Association (NYHA) class greater than or equal to II heart disease 10. Patients with a left ventricular ejection fraction (LVEF) below 50% by Multiple Uptake Gated Acquisition (MUGA) scan or echocardiography 11. Pre-existing motor or sensory neuropathy of grade greater than 1 for any reason 12. Patients with a history of hypersensitivity due to administration of drugs containing polyoxyethylene castor oil (Cremophor EL) (e.g., cyclosporin), or hardened castor oil (e.g., vitamin preparations for injection, etc.) 13. Other serious illness or medical condition including: 13.1. History of documented congestive cardiac failure 13.2. Angina pectoris requiring antianginal medication 13.3. Evidence of transmural infarction on ECG 13.4. Poorly controlled hypertension (e.g. systolic greater than 180 mm Hg or diastolic greater than 100 mm Hg; however, patients with hypertension which is well controlled on medication are eligible) 13.5. Clinically significant valvular heart disease 13.6. High-risk uncontrolled arrhythmias 14. Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and precluding informed consent or adversely affecting compliance to study drugs 15. Serious uncontrolled infections (bacterial or viral) or poorly controlled diabetes mellitus 16. Any of the following abnormal baseline haematological values: 16.1. Neutrophils less than 1.5 x10^9/L 16.2. Platelets less than 100 x 10^9/L 17. Any of the following abnormal laboratory tests: 17.1. Serum total bilirubin greater than 1.25 xULN (upper limit of normal) (except for patients with clearly documented Gilbert?s syndrome) 17.2. Alanine transaminase (ALT) or aspartate transaminase (AST) greater than 1.25 x ULN 17.3. Alkaline phosphatase greater than 1.25 x ULN 17.4. Serum creatinine greater than 1.5 x ULN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response in breast (pCR), defined as the absence of invasive cancer cells at pathological examination, measured when all patients complete surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall response rate measured when patients complete primary systemic therapy 2. Tolerability and safety of all proposed regimens | — |
Countries
Austria, Germany, Italy, Russian Federation, Spain
Outcome results
None listed