European Cooperative Study of Primary Systemic Therapy in Women with Operable Breast Cancer and T > 2 cm

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 486

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathological complete response in breast (pCR), defined as the absence of invasive cancer cells at pathological examination, measured when all patients complete surgery

Secondary Outcome Measures

Name	Time	Method
1. Overall response rate measured when patients complete primary systemic therapy<br>2. Tolerability and safety of all proposed regimens

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