NL-OMON55501已完成2 期
Phase I/prospective randomized phase II trial Of the Safety and Efficacy of tamoxifen in combination with the Isoform selective Pi3K inhibitor GDC-0032 compared with tamoxifen alONe in hormone receptor positive, HER2 negative, metastatic breast cancer patients with prior exposure to endocrine treatment (POSEIDON trial) - Poseidon
ederlands Kanker Instituut0 个研究点目标入组 120 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
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
- •- Minimum age for inclusion 18 years
- •- The patient has a WHO performance status * 2
- •- Premenopausal/Postmenopausal female breast cancer patient with histological
- •proven ER and/or PR positive, HER2 negative breast cancer (based on the most
- •recent assessment of ER and PR status from primary breast cancer or from
- •recurrent or metastatic disease). Premenopausal patient should also receive a
- •LHRH agonist.
- •- The patient*s breast cancer must be negative for HER2 over-expression by IHC
- •(IHC score *1+) or for HER2 gene amplification by FISH or CISH or SISH
- •- Patients must have either measurable or evaluable disease by RECIST criteria
- •version 1.1.
- •- The patient has recurrent or metastatic breast cancer that is refractory to
- •an endocrine therapy defined as the occurrence of either of the following while
- •the patient is on endocrine therapy:
- •*Disease progression of locally advanced or metastatic breast cancer
- •*Disease recurrence of early stage breast cancer (i.e., recurrence while
- •receiving adjuvant treatment with endocrine therapy)
- •- Availability of a representative tumour tissue specimen
- •- The patient has adequate organ and marrow function, as defined here:
- •* Absolute Neutrophil Count (ANC) * 1.5 x 109/L
- •* Hemoglobin (Hgb) * 9 g/dl (<=5.6 mmol/L)
- •* Platelets (plt) * 100 x 109/L
- •* AST/SGOT and ALT/SGPT * 2.5 x Upper Limit of Normal (ULN) (or < 5 x ULN in
- •case of liver metastasis)
- •* Serum bilirubin * 1.5 x ULN (or < 3 x ULN in case of known Gilbert syndrome)
- •* Serum creatinine * 1.5 x ULN or 24-hour clearance * 60 mL/min
排除标准
- •Exclusion Criteria
- •- Patients with premenopausal follicle stimulating hormone (FSH) and/or plasma
- •estradiol levels who are not treated with a LHRH agonist
- •- Prior treatment with PI3K-pathway-targeted therapies (including PI3K, PDK,
- •AKT and mTOR inhibitors) is not permitted, except for everolimus. Up to 50% of
- •all patients may be pretreated with everolimus.
- •- The following restrictions on prior anticancer therapy apply;
- •- Endocrine therapies or small molecule targeted (non-cytotoxic) inhibitors
- •(including investigational kinase inhibitors) within 2 weeks or 5 half-lives of
- •the compound or active metabolites, whichever is longer but not more than 4
- •weeks, before the first dose of the study treatment are not allowed
- •- Previous treatment with tamoxifen, unless tamoxifen was administered in the
- •adjuvant setting and stopped >1 year before metastatic relapse (exception:
- •patient who cross over to tamoxifen + GDC-0032 arm after progression on
- •tamoxifen+placebo)
- •- No more than 5 prior chemotherapeutic regimens for metastatic breast cancer
- •- Radiation therapy within 2 weeks before the first dose of study treatment,
- •unless of palliative intent, not compromising bone marrow function
- •- Cytotoxic chemotherapy within 3 weeks, or nitrosoureas or mitomycin C within
- •6 weeks before the first dose of the study treatment
- •- Antibody therapy within 4 weeks before the first dose of the study treatment
- •- Major surgery or not recovered from major surgery, within 4 weeks before the
- •first dose of study treatment
- •- The patient has not recovered from toxicity due to prior therapy to grade *1
- •or to pre-therapy baseline. Patients with grade 2 peripheral neuropathy or
- •grade 2 alopecia related to prior therapies are eligible
- •- The patient has untreated, symptomatic, or progressive brain metastases
研究者
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