breastcancer > 3 cm and/or metastatic disease of axilary lymfenodes
Conditions
Interventions
None listed
Sponsors
Catharina-ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - To evaluate clinical and pathological response to neoadjuvant chemotherapy - To evaluate the value of dynamic contrast-enhanced breast MRI in monitoring and predicting response to neoadjuvant chemotherapy. - To evaluate the value of circulating tumour cells in monitoring and predicting reponse to neoadjuvant chemotherapy. - To define gene expression profiles that can predict treatment response or failure by microarray analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To determine disease-free and overall survival. - To evaluate the use of radioactive labeled (125-I) seed as to localize tumour prior to chemotherapy to enable - after surgical excision (conservation therapy or mastectomy) pathological evaluation of tumour residue after chemotherapy | — |
Countries
Netherlands
Outcome results
None listed