Patients with locally advanced or large resectable HER2-negative breast cancer MedDRA version: 12.1 Level: LLT Classification code 10006195 Term: Breast cancer NOS stage II MedDRA version: 12.1 Level: LLT Classification code 10006196 Term: Breast cancer NOS stage III
Conditions
Interventions
Trade Name: Zoledronic Acid/Zometa
Product Name: Zometa
Pharmaceutical Form: Intravenous infusion
Trade Name: Neulasta
Product Name: pegfilgrastim
Pharmaceutical Form: Concentrate for solution for in
Sponsors
BOOG Study Center B.V
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Women presenting with large resectable or locally advanced breast cancer (T2 =2 cm and positive lymph nodes, T2 = 3cm? T3,T4, every N, M0) •Measurable disease (breast and/or lymph 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 109/l, neutrophils =1.5 x 109/l, platelets =100 x 109/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 •Patients must be accessible for treatment and follow-up 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
Exclusion criteria
Exclusion criteria: •Evidence of distant metastases (M1) •Prior 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the pathologic complete response (pCR) rate to neoadjuvant chemotherapy with or without zoledronic acid at surgery. ;Primary end point(s): The primary endpoint of this study is the pathologic complete response (pCR) rate to neoadjuvant chemotherapy with or without zoledronic acid at surgery. ;Secondary Objective: •Clinical response (partial and complete according to RECIST v 1.1) of neoadjuvant therapy correlated to pathological response. •Disease free survival and overall survival after 3 and 5 years •Tolerability (grade 3 / 4 CTC toxicities) of both regimens. •Pathology: ER/PR and HER2 heterogeneity in core biopsy vs. operation specimen. | — |
Countries
Netherlands
Outcome results
None listed