Clinical and pathological response rates to Neoadjuvant Hormone Therapy and Chemotherapy in patients with Luminal subtype breast tumors: a randomized, open-label, non-inferiority trial

Instituto de Medicina Integral Prof. Fernando Figueira - IMIP0 个研究点开始时间: 2021年12月6日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•Histological diagnosis of invasive breast carcinoma with Estrogen Receptor (ER) expression > 50%, Ki 67 ? 35%, HER2 negative and Progesterone Receptor (PR) > 20%;
•Tumor ? 2cm on ultrasound or Tumor < 2cm with at least 1 axillary lymph node diagnosed with metastatic involvement – Metastatic involvement should be defined by cytology (USG guided FNA of the suspected lymph node) or histology (suspected lymph node core biopsy or biopsy of sentinel lymph node performed before neoadjuvant therapy)

•Metastatic disease;
•Inflammatory breast cancer;
•Impossibility of surgical or drug treatment due to comorbidities such as decompensated heart failure or hematological and biochemical parameters within the patterns of patterns described:
•Hemoglobin < 7.0 g / dL;
•FA ?1.5 times the reference value;
•Neutrophil count < 1500 U /mm3 ;
•Platelet count < 100,000 U /µL;
•Serum creatinine > 1.5 mg / dL;
•Score > 2 on the ECOG Scale - Eastern Cooperative Oncology Group;
•Contraindication to the use of at least one of the drugs proposed for the study;
•Ongoing pregnancy.

发起方

Instituto de Medicina Integral Prof. Fernando Figueira - IMIP