JPRN-jRCT2031230096招募中3 期
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months. - CAMBRIA-1
Hibi Kazushige0 个研究点目标入组 430 人开始时间: 2023年5月26日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 430
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
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Women and Men, greater than or equal to 18 years at the time of screening (or per national guidelines)
- •- Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with high or intermediate risk of recurrence, based on clinical-pathological risk features, as defined in the protocol.
- •- Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy
- •- Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET (+/- CDK4/6 inhibitor)
- •- Prior adjuvant therapy with CDK4/6 inhibitors for 2 years is allowed
- •- Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1
- •- Adequate organ and marrow function
排除标准
- •- Inoperable locally advanced or metastatic breast cancer
- •- Pathological complete response following treatment with neoadjuvant therapy
- •- History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix or considered at very low risk of recurrence per investigator judgement) unless in complete remission with no therapy for a minimum of 5 years from the date of randomisation
- •- Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion precludes participation in the study or compliance
- •- Known LVEF <50% with heart failure NYHA Grade greater than or equal to 2
- •- Mean resting QTcF interval >480 ms at screening
- •- Concurrent exogenous reproductive hormone therapy or non-topical hormonal therapy for non-cancer-related conditions
- •- Any concurrent anti-cancer treatment not specified in the protocol with the exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors (eg, denosumab)
- •- Previous treatment with camizestrant, investigational SERDs/investigational ER targeting agents, or fulvestrant
- •- Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding
- •- Patients with known hypersensitivity to active or inactive excipients of camizestrant or drugs with a similar chemical structure or class to camizestrant. In pre-/peri-menopausal female and male patients, known hypersensitivity or intolerance to LHRH agonists, that would preclude the patient from receiving any LHRH agonist
研究者
相似试验
招募中
3 期
CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+/HER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of DiseaseBreast Cancer, Early Breast CancerJPRN-jRCT2061230074Hibi Kazushige550
进行中（未招募）
不适用
Randomized, open-label, phase III study to evaluate the efficacy of rituximab maintenance therapy in patients aged between 18 and 65 years inclusive undergoing first-line treatment for mantle cell lymphoma and exhibiting a response after autologous transplantation. - Manteau 2007 SJ LyMa (Young Subjects)Maintenance therapy in patients carriying a mantle cell lymphoma as response.MedDRA version: 14.1Level: PTClassification code 10061275Term: Mantle cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2007-004644-70-DEGOELAMS299
进行中（未招募）
不适用
A randomized, open-label Phase III study to assess efficacy and safety of bevacizumab in combination with capecitabine as first line treatment for elderly patients with metastatic colorectal cancer - AVEX: Avastin in Elderly with XelodaEUCTR2006-003293-10-GRF. Hoffmann-La Roche Ltd.430
进行中（未招募）
不适用
A randomized, open-label Phase III study to assess efficacy and safety of bevacizumab in combination with capecitabine as first line treatment for elderly patients with metastatic colorectal cancer - AVEX: Avastin in Elderly with XelodaFirst line metastatic colorectal carcinomaMedDRA version: 8.1Level: LLTClassification code 10052358Term: Colorectal cancer metastaticEUCTR2006-003293-10-SIF. Hoffmann-La Roche Ltd.430
进行中（未招募）
不适用
A randomized, open-label Phase III study to assess efficacy and safety of bevacizumab in combination with capecitabine as first line treatment for elderly patients with metastatic colorectal cancer - AVEX: AVastin in the Elderly with XelodaFirst line metastatic colorectal carcinomaMedDRA version: 8.1Level: LLTClassification code 10052358Term: Colorectal cancer metastaticEUCTR2006-003293-10-ATF. Hoffmann-La Roche Ltd.280