JPRN-jRCTs061180075
已完成
2 期
Open-label Phase II Study of Everolimus Plus Endocrine Therapy in Postmenopausal Women with ER+, HER2- Metastatic Breast Cancer. - Chloe trial
Shien Tadahiko0 个研究点目标入组 44 人2019年3月20日
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Metastatic Braest Cancer
- 发起方
- Shien Tadahiko
- 入组人数
- 44
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
These results indicated the additinal effect of mTOR inhibitor to AI, even if the tumor has sensitivity to AI monotherapy.
研究者
入排标准
入选标准
- •1, Patients who are histologically diagnosed as having breast cancer.
- •2, The cancer is immunohistochemically ER\-positive (\>10%) and HER2\- negative (0/1\+) (or HER2\-negative based on ISH testing).
- •3, Patients who have one or more measurable lesions according to RECIST (Ver. 1\.1\).
- •As for bone lesions, patients who have measurable osteolytic or osteolytic osteoblastic lesions by CT or MRI (\> 1cm in length) are eligible.
- •4, Patients with metastatic breast cancer that satisfy one of following two conditions:
- •1\) Patients with remote metastasis judged not to be indicated for surgical resection at the first visit.
- •2\) Patients with metastatic breast cancer except for local recurrence (the term local here refers to the chest wall surrounded by the following areas: upward to subclavian margin, downward to costal arch, inward to medial sternal margin and outward to the frontal margin of latissimus dorsi muscle). Patients with local recurrence which is not indicated for surgical resection due to diffuse lesions are eligible.
- •5, If patients received post\-operative endocrine therapy, a 12 month or longer period must have passed since the end of the last administration. History of post\-operative chemotherapy and elapsed time from chemotherapy, as well as the regimen of post\-operative endocrine therapy, do not matter.
- •6, Among patients who start the treatment with an AI agent within 5\-7 months previously. Patients who have not received chemotherapy or received just 1 regimen of chemotherapy.
- •7, Patients who have no history of treatment with everolimus.
排除标准
- •1, Patients who have active double cancer (simultaneous double cancer or metachronous double cancer within 5 years of disease\-free period). Carcinoma in situ (intraepithelial carcinoma and mucosal carcinoma) that is judged to be already cured will not be classified as active double cancer
- •2, Patients who have a history of serious drug hypersensitivity.
- •3, Patients who have serious concomitant diseases (including pulmonary fibrosis or interstitial pneumonia, uncontrollable diabetes, serious cardiac dysfunction, renal failure, hepatic insufficiency, cerebrovascular disease and ulcer(s) requiring a blood transfusion).
- •4, Patients who have an active infectious disease requiring systemic treatment.
- •\*Patients who are HBs antigen positive and HBc antibody positive, and/or HBs antibody positive.
- •\*Patients who are infected with HCV or have a history of HCV infection.
- •5, Patients who have active hemorrhagic diathesis or who are being treated with an oral vitamin K antagonist
- •6, Patients with cerebral metastasis that is symptomatic or requires treatment.
- •7, Patients who have been administered medicines known as potent CYP3A inhibitors or CYP3A inducers (rifabutin, rifampicin, clarithromycin, ketoconazole, itraconazole, voriconazole, ritonavir, or telithromycin).
- •8, Patients who have been treated with hormone replacement therapy.
结局指标
主要结局
未指定
相似试验
终止
2 期
Pilot Study of mTOR Inhibitor Therapy in Peutz-Jeghers SyndromePeutz-Jeghers SyndromeNCT00811590University of Utah3
已完成
2 期
Phase II Study of Everolimus Combined With Octreotide LAR to Treat Advanced GI NETGastrointestinal NeoplasmsNCT01567488Grupo Espanol de Tumores Neuroendocrinos43
已完成
2 期
SARC016: Study of Everolimus With Bevacizumab to Treat Refractory Malignant Peripheral Nerve Sheath TumorsMalignant Peripheral Nerve Sheath TumorsMPNSTSarcomaNCT01661283Sarcoma Alliance for Research through Collaboration25
已完成
2 期
S0722: Everolimus in Treating Patients With Pleural Malignant Mesothelioma That Cannot Be Removed By SurgeryMalignant MesotheliomaNCT00770120SWOG Cancer Research Network61
终止
2 期
Everolimus in Treating Older Patients With Mantle Cell Lymphoma Previously Treated With First-Line or Second-Line ChemotherapyLymphomaNCT00727207Technical University of Munich35