NL-OMON45124已完成2 期
AN OPEN-LABEL, PHASE Ia/Ib/IIa STUDY OF GDC 0810 SINGLE AGENT OR IN COMBINATION WITH PALBOCICLIB AND/OR AN LHRH AGONIST IN WOMEN WITH LOCALLY ADVANCED OR METASTATIC ESTROGEN RECEPTOR POSITIVE BREAST CANCER - Genentech GO29642
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 4
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
- 18 至 99（—）
入选标准
- •Phase IIa Inclusion Criteria:
- •- Signed and dated informed consent document indicating that the subject (or legally
- •acceptable representative) has been informed of all the pertinent aspects of the trial prior to
- •- 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 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 0 or 1
- •- Adequate organ function
- •- Cohort A only: Confirmed ESR1 mutation of the LBD and presence of measurable
- •disease as per Response Evaluation Criteria in Solid Tumors (RECIST)
- •version 1.1 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 prior
- •treatment with an aromatase inhibitor in the advanced/metastatic
- •- Cohort B1 only: no prior fulvestrant allowed
- •- Cohort B2 only: prior fulvestrant allowed
排除标准
- •Phase IIa Exclusion Criteria
- •- Untreated or symptomatic CNS metastases
- •- Patients with a history of endometrial polyps, endometrial cancer, atypical endometrial hyperplasia, or other significant endometrial disorders should be excluded unless they have undergone total hysterectomy and there is no evidence of active disease.
- •- 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
- •- Active inflammatory bowel disease e.g. Crohn*s disease or ulcerative colitis), any active bowel inflammation (including diverticulitis), 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
- •- Cohort A1, A2, and Cohort B2 only: > 1 prior chemotherapy in the
- •advanced/metastatic setting
- •- Cohort B1 only: prior chemotherapy in the advanced/metastatic
研究者
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