EUCTR2012-000134-19-DE进行中（未招募）不适用
A randomised, phase 2 trial of AEZS-108 in chemotherapy refractory triple negative (ER/PR/HER2-negative) LHRH-R positive metastatic breast cancer - AEZS-108 in patients with LHRH receptor positive breast cancer
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 74
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
- •1) Woman = 18 years of age
- •2) Histologically documented breast cancer (either primary or metastatic site) that is
- •(i) ER-negative,
- •(ii) PR-negative, and
- •(iii) HER2-negative, defined by IHC (immunohistochemistry; IHC 0/1, non-overexpressing) or FISH (fluorescence in situ hybridization; FISH negative) or CISH (chromogen in situ hybridization; CISH negative).
- •3) Expression LHRH receptor confirmed by IHC on archival (or current biopsy of breast tumor or metastatic site) breast cancer tissue.
- •4) Progressive disease after failure of 1 to 3 prior chemotherapy regimens for recurrent or metastatic (Stage IV) disease (prior adjuvant/neoadjuvant therapy is allowed).
- •5) Measurable disease by RECIST 1.1 criteria; at least one target lesion that has not been previously irradiated.
- •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 64
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Eastern Cooperative Oncology Group (ECOG) performance status > 2
- •2. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or recent myocardial infarction (within 6 months of enrollment)
- •3. Leptomeningeal disease or brain metastases requiring steroids or other therapeutic intervention.
- •4. Left ventricular ejection fraction (LVEF) < 50%, determined by echocardiogram or MUGA scan
- •5. Compromised organ or marrow function as evidenced by any of the following:
- •- thrombocyte count: < 100x109/L;
- •- absolute neutrophil count (ANC): <1.5x109/L;
- •- hemoglobin: <6.0 mmol/L (<9 g/100mL);
- •- AS(A)T, AL(A)T: > 2.5 times upper limit of normal range (ULN)
- •(>5x ULN if clearly related to liver metastases);
- •- bilirubin: >1.5 mg/dL;
- •- creatinine: >1.5 mg/dL or creatinine clearance <40 mL/min.
- •6. Systemic anticancer therapy or radiotherapy within 21 calendar days of the first dose of study drug*).
- •* also excluded are patients with anticipated ongoing concomitant anticancer therapy during the study
- •7. History of allergic reaction to anthracycline or peptide drugs, including LHRH agonists.
- •8. Prior exposure to anthracyclines or anthracenediones for the treatment of metastatic breast cancer including liposomal doxorubicin (Doxil), doxorubicin, daunorubicin, or mitoxantrone.
- •9. Prior adjuvant anthracyclines with a cumulative anthracycline dose equivalent to = 300 mg/m2 (e.g. 600 mg/m2 in case of epirubicin)
- •10. Ongoing therapeutic anticoagulation.
- •11. Patients who are not surgically sterile or post-menopausal must agree to use for the duration of the study reliable methods of birth control defined as:
- •- complete abstinence;
- •- any intrauterine device (IUD) with published data showing that the lowest expected failure rate is <1% per year; or
- •- any other methods with published data showing that the lowest expected failure rate is less than 1% per year.
- •Lack of suitability for the trial
- •12. Use of LHRH agonist or antagonist treatment within 6 months prior to or during the study
- •13. Investigational therapy within 30 calendar days of the first scheduled day of protocol treatment (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication).
- •14. Prior treatment with AEZS-108.
- •Administrative reasons
- •15. Lack of ability or willingness to give informed consent and comply with the protocol.
- •16. Anticipated non-availability for study visits/procedures.
研究者
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