EUCTR2015-000106-19-ES
进行中（未招募）
1 期
A PHASE II, OPEN-LABEL, RANDOMIZED STUDY OF GDC-0810 VERSUS FULVESTRANT IN POSTMENOPAUSAL WOMEN WITH ADVANCED OR METASTATIC ER+/HER2- BREAST CANCER RESISTANT TO AROMATASE INHIBITOR THERAPY
适应症Advanced or Metastatic ER+/HER2- Breast CancerMedDRA version: 18.0Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
相关药物FASLODEX
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Advanced or Metastatic ER+/HER2- Breast Cancer
- 发起方
- Genentech, Inc
- 入组人数
- 152
- 状态
- 进行中（未招募）
- 最后更新
- 8年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •\- Postmenopausal women with histologically or cytologically confirmed invasive, estrogen receptor positive (ER\+)/ human epidermal growth factor receptor 2 negative (HER2\-) (defined by local guidelines) metastatic or inoperable (not amenable to resection or other local therapy with curative intent), locally advanced breast cancer
- •\- Patients for whom endocrine therapy (e.g., fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines
- •\- Radiologic/objective evidence of recurrence or progression to the most recent systemic therapy for breast cancer
- •\- Radiologic/objective evidence of breast cancer recurrence or progression while on or within 6 months after the end of adjuvant treatment with an AI, or progression while on or within 1 month after the end of prior AI treatment for locally advanced or MBC
- •\- Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1\.1 or non\-measurable, evaluable disease with at least one evaluable bone lesion by RECIST v1\.1 based on radiologic scans within 28 days of Day 1 of Cycle 1
- •\- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- •\- Adequate hematologic and end\-organ function
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
排除标准
- •\- HER2 positive disease (immunohistochemistry \[IHC] 3\+ staining, fluorescence in situ hybridization \[FISH] positive, and/or chromogenic in situ hybridization \[CISH] positive)
- •\- Prior treatment with fulvestrant
- •\- Prior anti\-cancer therapy within 2 weeks prior to Cycle 1 Day 1
- •\- Prior radiation therapy within 2 weeks prior to Cycle 1 Day 1
- •\- Prior treatment with \>1 cytotoxic chemotherapy regimens or \>2 endocrine therapies for advanced or metastatic disease
- •\- Ongoing, acute treatment\-related toxicity that has not resolved to Grade \<\=1 or been deemed stable by the investigator
- •\- Concurrent hormone replacement therapy
- •\- Known untreated or active central nervous system metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
- •\- History of other malignancy within the previous 5 years
- •\- Inability or unwillingness to swallow pills or receive intramuscular injections
结局指标
主要结局
未指定
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