NL-OMON30125
Withdrawn
Phase 2
Study of neo adjuvant chemotherapy in large and/or lymphenode positive breast cancer (stage IIB-III pT2> 3cm). Multicentre - phase II - trial. - Neoadjuvant chemotherapy in large and/or lymphenode positive breast cancer.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Catharina-ziekenhuis
- Enrollment
- 50
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \< 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.
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
Outcomes
Primary Outcomes
Not specified
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