EUCTR2012-000558-71-ES进行中（未招募）不适用
An Open Label Multicenter Phase 2 Window Of Opportunity Study Evaluating Ganetespib (STA-9090) Monotherapy In Women With Previously Untreated Metastic HER2 Positive Or Triple Negative Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
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. Female ? 18 years of age; 2. Pathologically confirmed diagnosis of invasive breast cancer - If the disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology or histology - Inflammatory breast cancer (IBC) is permitted based on following criteria: Clinically evaluable skin disease (erythema, edema, peau d?orange, or ulcerations), with underlying mass detected by PET; and/or The presence of measurable disease detected by CT/MRI; 3. Stage IV disease (AJCC Cancer Staging Manual, 7th edition, 2010) - Stage IIIb disease permitted for inflammatory breast cancer only; 4. HER2+ patients must have relapsed following prior trastuzamab, or other approved anti-HER2 agent in the adjuvant setting. At least six months must have elapsed since the discontinuation of prior adjuvant therapy; 5. Documented HER2 and hormonal receptor status according to local laboratory analysis - Cohort A: HER2+ disease in primary or metastatic tumor tissue, regardless of hormone receptor status, defined as either: a. FISH positive; b. or +3 by immunohistochemistry (IHC) alone; c. or +2 by IHC and FISH positive - Cohort B: HER2 negative, ER negative, and PR negative in primary or metastatic tumor tissue; 6. ECOG Performance Status 0 ? 1
- •7. A biopsy is to be taken at study entry for all patients with an accessible tumor. Patients with inaccessible tumor may substitute archived tissue (block or 10 unstained slides) with prior sponsor approval; 8. Measurable disease per RECIST (1.1), with the exception of patients with IBC for whom disease visible on PET is acceptable; 9. Adequate hematologic function defined as: Absolute neutrophil count (ANC) greater than/equal to 1.5 x 10 9/L; hemoglobin greater than/equal to 9 g/dL; Platelets greater than/equal to 100 greater than/equal to 10 9/L; 10. Adequate hepatic function defined as: Albumin greater than/equal to 3 g/dL; Serum total bilirubin greater than/equal to 1.5 x ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) greater than/equal to 1.5, greater than/equal to ULN without liver metastases; greater than/equal to 5; greater than/equal to ULN if documented liver metastases; 11. Adequate renal function defined as: Serum creatinine greater than/equal to 1.5 mg/dL or calculated creatinine clearance (CLcr) per Cockgroft-Gault formula greater than/equal 50 mL/min; 12. Negative serum pregnancy test at study entry for patients of childbearing potential. Patients of childbearing potential must agree to use two adequate contraception methods (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment and for 30 days after the last dose of study drug; 13. Ability to understand, and willingness to sign, a written informed consent document and to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Prior systemic therapy in the 1st line setting for metastatic breast cancer - NOTE: Patients intolerant to 1st line systemic therapy without any evidence of progressive disease may be considered for inclusion only after consultation with the sponsor medical monitor; NOTE: Prior therapy of IBC patients in the 1st line setting is permitted given the rarity of the disease; NOTE: Patients with ER+ and/or PR+ and HER2+ disease who received one prior hormonal therapy in the metastatic setting are eligible; however, at least 2 weeks must have elapsed since the last dose of hormonal treatment; 2. De novo diagnosed patients with HER2+ disease; 3. Presence of active or untreated CNS metastases as determined by MRI/ CT scan performed during screening. NOTE: Patients with stable CNS metastases are eligible; 4. Active malignancies other than MBC within the last 5 years except adequately treated in situ carcinoma of the cervix uteri, or basal or squamous cell carcinoma of the skin.; 5. Bone as the only site of metastatic disease from breast cancer; 6. Prophylactic use of supportive therapy for skeletal related events in patients without bone disease is not permitted. NOTE: Supportive therapy for skeletal related events (e.g., bisphosphonate, pamidronate, or denosumab) is allowed; however, treatment must be initiated prior to, or within 7 days after, the first dose of ganetespib; 7. Prior radiotherapy to the only area of measurable disease. NOTE: Radiotherapy to a limited area other than the sole site of measurable disease is allowed, if received prior to initiation of ganetespib treatment. Patients must have completed treatment and recovered from all acute treatment-related toxicities prior to administration of first dose of ganetespib; 8. Pregnancy or lactation; 9. Known serious cardiac illness or medical conditions including but not confined to: ? History of documented congestive heart failure (CHF), New York Heart Association class II/III/IV, with a history of dyspnea, orthopnea or edema that requires current treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, beta-blockers or diuretics. NOTE: Use of these medications for the treatment of hypertension is allowed; ? Baseline QTc > 470 msec or history of QT prolongation while taking other medications; ? High-risk uncontrolled arrhythmias (ventricular arrhythmias, high-grade AV-block, supra-ventricular arrhythmias which are not adequately rate-controlled); ? Arrhythmias that require current treatment with the following anti-arrhythmic drugs: flecainide, moricizine or propafenone; ? Active coronary artery disease with a history of myocardial infarction, angina pectoris, angioplasty or coronary bypass surgery; 10. Weight loss ?10% within the 4 weeks prior to administration of first dose of ganetespib; 11. Unresolved grade 3 and 4 toxicities from prior cancer therapy.; 12. Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV) positive patients receiving combination antiretroviral therapy, severe or systemic infection, or psychiatric illness/social situations that would limit compliance with study requirements; 13. Other severe acute or chronic medical condition or abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or that in the judgment of the investigator would make the patient inappropriate for entry
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