Study of neo adjuvant chemotherapy in large and/or lymphenode positive breast cancer (stage IIB-III pT2> 3cm). Multicentre - phase II - trial.

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

•Women presenting with locally advanced stage IIB-III breast cancer pT2 > 3 cm, and/or clinically proven N+ disease. Exclusion cT4. (TNM classification 2002).
•No prior surgery other than biopsy and no prior chemotherapy or radiation therapy.
•Age > 18 years and age < 60 years.
•Karnofsky Performance status index > 80%
•Estrogen and/or progesterone receptor analysis performed on the primary tumour. Results must be known by the end of chemoptherapy in order to decide whether hormonal therapy is indicated.
•Her2/neu receptor analysis performed on the primary tumour.
•Adequate bone marrow (within 14 days prior to registration):WBC > 3.0 x 109/l, neutrophils > 1.5 x 109/l, platelets > 100 x 109/l, hemoglobin > 7 mmol/l.
•Adequate liver function (within 21 days prior to registration):bilirubin < 1 x upper limit of normal (UNL) range, ALAT and/or ASAT < 2.5 x UNL, Alkaline Phosphatase < 5 x UNL.
•Adequate renal function (within 21 days prior to registration):Creatinine < 120 µmol/L; if limit values reached, the calculated creatinine clearance should be > 60 mL/min.
•No sign of metastatic disease on X-thorax, liver ultrasound or nuclear bone scan.
•Cardiac LVEF evaluation by ECHO or MUGA (within normal limits).
•Patients must be accessible for treatment and follow-up.
•Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential.
•Having signed written informed consent according to the local Ethics Committee requirements.

Exclusion Criteria

•Prior systemic anticancer therapy for any cancer (immunotherapy, hormonaltherapy, genetherapy, chemotherapy).
•Prior anthracycline-based or taxoid-containing therapy (paclitaxel, docetaxel) for any malignancy.
•Prior radiation therapy for breast cancer.
•Patients with advanced pulmonary disease.
•Peripheral neuropathy > grade 2 whatever the cause.
•Clinical evidence of CNS disease.
•Patients with a history of another malignancy (except basal cell skin carcinoma and carcinoma-in-situ of the uterine cervix) within 5 years of study entry.
•Pregnant or lactating women, or potentially fertile women not using adequate contraception.
•Clinically T4

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- To evaluate clinical and pathological response to neoadjuvant chemotherapy<br /><br><br /><br>- To evaluate the value of dynamic contrast-enhanced breast MRI in monitoring<br /><br>and predicting response to neoadjuvant chemotherapy.<br /><br><br /><br>- To evaluate the value of circulating tumour cells in monitoring and<br /><br>predicting reponse to neoadjuvant chemotherapy.<br /><br><br /><br>- To define gene expression profiles that can predict treatment response or<br /><br>failure by microarray analysis.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To determine disease-free and overall survival.<br /><br><br /><br>- To evaluate the use of radioactive labeled (125-I) seed as to localize tumour<br /><br>prior to chemotherapy to enable - after surgical excision (conservation<br /><br>therapy or mastectomy) pathological evaluation of tumour residue after<br /><br>chemotherapy </p><br>