CTRI/2018/09/015755招募中未知
Pilot study to evaluate the biodistribution and dosimetry of 177Lu â?? Trastuzumab in HER2 receptor positive metastatic breast carcinoma and its toxicity and efficacy profile.
Intramural Tata Memorial Centre0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Inclusion criteria (all of the following)
- •a) Age more than 18 years and less than equal to 70 years.
- •b) Signed, written informed consent (approved by the Institutional Ethics Committee [IEC]), prior to any study procedure.
- •c) Histologically confirmed and documented adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative section.
- •d) Male or female patient with documented HER2 positive [defined as either 3 plus by immunohistochemistry or with evidence of gene amplification (more than 2.0) by fluorescence in situ hybridization (FISH) breast cancer].
- •e) Patients with at least 1 measurable or evaluable lesion as per RECIST criteria 1.1 and showing FDG uptake on a FDG PETCT plus CECT study.
- •f) Patients with metastatic breast cancer who have received at least 1 line of treatment (with or without HER2 targeted therapy) in the metastatic setting and have shown disease progression after the treatment and have received one line of neo (adjuvant) chemotherapy (with or without HER2 targeted therapy). Thus patient should have received at least 2 lines of chemotherapy including the neo (adjuvant) one.
- •g) Eastern Cooperative Oncology Group (ECOG) performance status(PS) 2 or less.
- •h) Known or documented LVEF of 50 percent or greater
- •i) Adequate organ function as determined by the following Laboratory results:
- •i. Hemoglobin more than equal to 9 Grams Per Decilitre
- •ii. Platelet Count more than equal to 100,000 x 10e9 per liter
- •iii. Serum Creatinine less than equal to 1.1 milligram per deciliter x 1.5 times of upper limit
- •iv. Aspartate aminotransferase (SGOT [AST] or Alanine aminotransferase (SGPT)[ALT]) less than equal to 2.5 times the upper limit of institutional normal values. or less than equal to 5 x ULN in presence of liver metastases.
- •j) A negative serum β-HCG test for women of childbearing potential (premenopausal, or less than 12 months of amenorrhea post-menopause, and women who have not undergone surgical sterilization [i.e., absence of ovaries and or uterus]).
排除标准
- •Exclusion criteria
- •a) Patients who have received trastuzumab in the preceding 30 days prior to date of 1st study treatment.
- •b) Patients showing absence of FDG uptake on the FDG PETCT plus CECT scan.
- •c) Previous Grade 3 or higher allergic reaction to trastuzumab that resulted in discontinuation of trastuzumab therapy
- •d) Patients who had received extensive radiotherapy (defined as radiation to more than 50 percent of marrow space) this is likely to compromise the marrow reserve.
- •e) Active autoimmune or history of autoimmune disease.
- •f) Pregnant and lactating women.
- •g) Patients who are unable to lie in supine position.
- •h) Patients with no 177Lu Trastuzumab uptake in any target lesion on dosimetric study.
- •i) Dyspnea at rest due to complications of advanced malignancy, or other disease requiring continuous oxygen therapy.
- •j) Brain Metastasis.
- •k) Positive for human immunodeficiency virus (HIV) infection.
- •l) History of congestive heart failure of any New York Heart Association (NYHA) class.
- •m) Clinically significant valvular heart disease or uncontrollable high-risk cardiac arrhythmia.
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