EUCTR2010-020395-28-DK进行中（未招募）1 期
A Randomized, Double-Blind Phase 2 trial of Exemestane +/- MM-121 in Postmenopausal Women with Locally Advanced or Metastatic Estrogen Receptor Positive (ER+) and/or Progesterone Receptor Positive (PR+), Her2 negative Breast Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
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
- •In order to be included in the study, patients must have/be:
- •5.5.1. Progressed following treatment with prior anti-estrogen therapy in the locally advanced or metastatic setting, OR progressed during adjuvant treatment (or within 6 months following adjuvant treatment) with a non-steroidal aromatase inhibitor and/or tamoxifen
- •5.5.2. Histologically or cytologically confirmed ER+ and/or PR+ and Her2 negative breast cancer
- •5.5.3. Documented locally advanced or metastatic disease with at least one radiologically measurable lesion as defined by RECIST v1.1
- •Exception: patients with bone-only metastatic disease are eligible if they have at least 2 lesions on a bone scan or other imaging modality (e.g. X-Ray, CT, PET-CT or MRI) and have documented disease progression on prior therapy based on the appearance of new lesions
- •5.5.4. Able to understand and sign an informed consent (or have a legal representative who is able to do so)
- •5.5.5. Postmenopausal female patients, as defined by the following:
- •- 5 years since onset of menopause
- •- Luteinizing hormone/follicle-stimulating hormone levels in the postmenopausal range in women whose
- •menopause occurred less than 5 years before inclusion
- •5.5.6. Unstained tumor slides from tumor tissue available for analysis
- •5.5.7. ECOG Performance Score (PS) of = 2
- •5.5.8. Adequate bone marrow reserves as evidenced by:
- •- ANC > 1,500/µl without the use of hematopoietic growth factors; and
- •- Platelet count > 100,000/µl; and
- •- Hemoglobin > 9 g/dL
- •5.5.9. Adequate hepatic function as evidenced by:
- •- Serum total bilirubin = 1.5 x ULN
- •- Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and Alkaline Phosphatase = 2.5 x ULN (=5 x ULN is acceptable if liver metastases are present; = 5 x ULN of Alkaline Phosphatase is acceptable if bone
- •metastases are present)
- •5.5.10. Adequate renal function as evidenced by a serum creatinine = 1.5 x ULN
- •5.5.11. Recovered from clinically significant effects of any prior surgery, radiotherapy or other antineoplastic
- •therapy. Patients with a known peripheral neuropathy must present as Grade 1 or less, according to National
- •Cancer Institute common terminology criteria [NCI CTCAE], version 4.0, to be eligible for inclusion.
- •5.5.12. 18 years or above of age
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Patients must meet all the inclusion criteria listed above and none of the following exclusion criteria:
- •5.6.1. Received prior treatment with exemestane
- •5.6.2. Received more than one prior chemotherapy regimen in the metastatic setting
- •5.6.3. Extensive visceral disease (rapidly progressive, life -threatening metastases, including symptomatic lymphangitic metastases)
- •5.6.4. Symptomatic CNS disease
- •5.6.5. History of another malignancy in the last 5 years. Patients with prior history of in-situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone and have been continuously disease free for at least 5 years.
- •5.6.6. Active infection or an unexplained fever > 38.5°C during screening visits or on the first scheduled day of
- •dosing, which in the investigator’s opinion might compromise the patient’s participation in the trial or affect the study outcome. At the discretion of the investigator, patients with tumor fever may be enrolled
- •5.6.7. Known hypersensitivity to any of the components of MM-121 or who have had hypersensitivity reactions to fully human monoclonal antibodies
- •5.6.8. Received other recent antitumor therapy including:
- •- Investigational therapy administered within the 30 days prior to the first scheduled day of dosing in this study
- •- Radiation or other standard hormonal therapy within 14 days prior to the first scheduled dose in this study,
- •including, in addition if necessary, the timeframe for any actual or anticipated toxicities from such radiation or
- •5.6.9. NYHA Class III or IV congestive heart failure or LVEF < 55%. Patients with a significant history of cardiac disease (i.e. uncontrolled blood pressure, unstable angina, myocardial infarction within 1 year or ventricular arrhythmias requiring medication) are also excluded
- •5.6.10. Recent (within 1 year) cerebral vascular accident (CVA)
- •5.6.11. History of allergic reactions attributed to compounds of similar chemical or biologic composition as exemestane
- •5.6.12. Planned bisphosphonate therapy which has not been initiated prior to randomization; bisphosphonate therapy for bone metastases is allowed; however, treatment must be initiated prior to the first dose of randomized therapy
- •5.6.13. Any other medical condition deemed by the Investigator to be likely to interfere with a patient’s ability to
- •sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
研究者
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