Effect of neoadjuvant treatment with zoledronic acid and chemotherapy in women with locally advanced triple negative breast cancer

Intramural fund of JIPMER0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Histologically proven invasive carcinoma of breast
•2.Locally advanced disease for neoadjuvant chemotherapy as per tumor clinic discussion.
•3.Triple negative subtype i.e., Hormone negative (ER and PR score 0,
•HER2-negative (HER2 0 or 1+ on immunohistochemistry, or 2+ on immunohistochemistry and negative on fluorescence in situ hybridization-FISH).
•4.Women of age 18- 70
•5.Eastern Cooperative Oncology Group performance status of 0â??1
•6.Left ventricular ejection fraction (LVEF) at least 50% by echocardiography
•7.Laboratory results within 3 weeks prior to starting treatment
•a. Absolute neutrophil count >= 1,500/mm3
•b. Platelet count >= 100,000/mm3
•c. Hemoglobin >= 8 g/dl (no blood transfusion within the previous 2 weeks)
•d. Bilirubin <= 1.5 x upper limit of normal (ULN)
•e. AST and ALT <= 3 x ULN
•f. Alkaline phosphatase <= 5 x ULN
•g. Creatinine <= 1.5 x ULN or estimated creatinine clearance >60ml/min/1.72m2.

•1.Prior use of bisphosphonates for same or other indications
•2.Symptomatic or biochemical hypocalcemia (Ca <7.4 with correction to albumn levels)
•3.Atrial fibrillation on ECG
•4.Poor dental hygiene or lack of dental fitness (as ascertained by dental surgeonâ??s evaluation pretreatment)
•5.Women who are pregnant or breastfeeding
•6.Patients who are enrolled into or participating in any other clinical trial in past 3 months.

发起方

Intramural fund of JIPMER