BOOG Study Center
J.R. Kroep, J.W.R. Nortier, G.J. Liefers
A. Charehbili, A.E. van Leeuwen-Stok
Leiden University Medical Center Datacenter Surgery K6-R P.O. Box 9600, 2300 RC Leiden Phone +31 71 526 3500 Fax +31 71 526 6744 ClinicalResearchCenter@lumc.nl E-mail datacenter@lumc.nl
IKNL
Funding by KWF
De database is gesloten op 6-9-2018. Follow-up is beperkt tot 5 jaar.
Randomization: Arm A: 6x TAC with Zoledronic acid Arm B: 6x TAC without Zoledronic acid
Primary objective: To determine the value of adding zoledronic acid to neoadjuvant chemotherapy with TAC in patients with large resectable or locally advanced HER2-negative breast cancer. Secondary objectives: To evaluate the clinical response, correlated to the pathological responses of both treatment arms. To evaluate the disease free survival and overall survival. To evaluate the safety and tolerability of adding zoledronic acid to neoadjuvant chemotherapy. To evaluate heterogeneity of the ER/PR and HER2 measurement of the core biopsy and the operation specimen.
Primary endpoint:
Secondary endpoints:
Inclusion: Women presenting with large resectable or locally advanced breast cancer (T2,T3,T4, every N, M0) Measurable disease (breast and/or ymph nodes) Histological proven HER2-negative breast cancer in the core biopsy material. Age ≥18 years WHO 0-2 Adequate bone marrow function (within 14 days prior to registration): WBC ≥3.0 x 10E9/l, neutrophils ≥1.5 x 10E9/l, platelets ≥100 x 10E9/l Adequate liver function (within 4 weeks prior to start treatment): bilirubin ≤1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase ≤5 x UNL Adequate renal function: the calculated creatinine clearance should be ≥50 ml/min Exclusion: Evidence of distant metastases (M1) History of breast cancer Prior breast surgery other than biopsy Prior chemotherapy or radiation therapy Previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix. Prior bisphosphonate usage. Peripheral neuropathy > grade 2, whatever the cause Serious other diseases as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias. Current active dental problems including dental abscess or infection of the jawbone (maxilla or mandible), or a current or prior diagnosis of osteonecrosis of the jaw requiring maxillofacial surgery.Known hypersensitivity reaction to any of the components of the treatment Pregnancy or lactating
