EUCTR2014-004852-77-ES进行中（未招募）1 期
AN OPEN-LABEL, PHASE I/IIA STUDY OF GDC-0810 IN POSTMENOPAUSAL WOMEN WITH LOCALLY ADVANCED OR METASTATIC ESTROGEN RECEPTOR POSITIVE BREAST CANCER
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 141
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •- Histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either locally recurrent disease not amenable to resection or radiation therapy with curative intent, or metastatic disease, both progressing after at least 6 months of hormonal therapy for ER+ breast cancer
- •- ER-positive, HER2-negative
- •- At least 2 months must have elapsed from the use of tamoxifen
- •- At least 6 months must have elapsed from the use of fulvestrant
- •- At least 2 weeks must have elapsed from the use of any other anticancer hormonal therapy
- •- At least 3 weeks must have elapsed from the use of any chemotherapy
- •- Females, 18 years of age or older
- •- Postmenopausal status
- •- Eastern Cooperative Oncology Group (ECOG) performance status
- •- Adequate organ function
- •Phase II portion - all above inclusion criteria, except:
- •- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •- At least 6 months must have elapsed from the use of fulvestrant not
- •- Cohort A only: Confirmed ESR1 mutation and presence of measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or evaluable bone disease
- •- Cohort A1 only: no prior fulvestrant allowed; at least 2 months must have elapsed from the use of tamoxifen
- •- Cohort A2 only: prior fulvestrant allowed
- •- Cohort B only: disease progression following no more than 1 prior treatment with an aromatase inhibitor in the advanced/metastatic setting
- •- Cohort B1 only: no prior fulvestrant allowed
- •- Cohort B2 only: prior fulvestrant allowed
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 131
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- Untreated or symptomatic CNS metastases
- •- Endometrial disorders
- •- More than 2 prior chemotherapy in the advanced/metastatic setting (prior adjuvant chemotherapy is allowed so long as it occurred >/= 12 months prior to enrollment)
- •- Current treatment with any systemic anticancer therapies for advanced disease or any systemic experimental treatment on another clinical trial
- •- Any significant cardiac dysfunction within 12 months prior to enrollment
- •- Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or upper gastrointestinal surgery including gastric resection
- •- Known human immunodeficiency virus infection
- •- Major surgery within 4 weeks prior to enrollment
- •- Radiation therapy within 2 weeks prior to enrollment
- •Phase II portion - all above exclusion criteria, plus:
- •- Cohort A1, A2, and Cohort B2 only: > 1 prior chemotherapy in the advanced/metastatic setting
- •- Cohort B1 only: prior chemotherapy in the advanced/metastatic setting
研究者
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