European Cooperative Study of Primary Systemic Therapyin Women with Operable Breast Cancer and T > 2 cmEstudio Cooperativo Europeo de Terapia Sistémica Primaria en Mujeres con Cáncer de Mama Operable y T > 2cm - ECTO II
- Conditions
- Women presenting for the first time with operable breast cancer who have not received any previous treatment for an invasive malignancy.
- Registration Number
- EUCTR2004-004957-24-ES
- Lead Sponsor
- Fondazione Michelangelo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 486
1. Female patients, presenting for the first time with unilateral operable breast cancer > 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 >= 18 years
5. ECOG Performance Status =< 1
6. Availability of HER2 status on immunohistochemistry
7. Availability of progesterone receptor status
8. Primary tumor 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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 >= II heart disease.
10. Patients with a left ventricular ejection fraction (LVEF) below 50% by MUGA scan or echocardiography
11. Pre-existing motor or sensory neuropathy of grade > 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: history of documented congestive cardiac failure; angina pectoris requiring antianginal medication; evidence of transmural infarction on ECG; poorly controlled hypertension (e.g. systolic > 180 mm Hg or diastolic >100 mm Hg; however, patients with hypertension which is well controlled on medication are eligible); clinically significant valvular heart disease; 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 hematological values: neutrophils < 1,500, platelets < 100,000
17. Any of the following abnormal laboratory tests: serum total bilirubin > 1.25 x ULN (upper limit of normal) (except for patients with clearly documented Gilbert’s syndrome), alanine transaminase (ALT) or aspartate transaminase (AST) > 1.25 x ULN, alkaline phosphatase > 1.25 x ULN, serum creatinine > 1.5 x ULN
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method