PER-082-14尚未招募未知
PHASE I STUDY OF THE COMBINATION OF TRASTUZUMAB EMTANSINE (T-DM1) AND CAPECITABINE IN HER2-POSITIVE METASTATIC BREAST CANCER AND HER2-POSITIVE LOCALLY ADVANCED OR METASTATIC GASTRIC CANCER PATIENTS, FOLLOWED BY A RANDOMIZED, OPEN-LABEL PHASE II STUDY OF TRASTUZUMAB EMTANSINE AND CAPECITABINE VERSUS TRASTUZUMAB EMTANSINE ALONE IN HER2-POSITIVE METASTATIC BREAST CANCER
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
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 80（—）
入选标准
- •1. Male or female.
- •2. Age ≥ 18 years old.
- •3. Signed informed consent before any study-specific procedure.
- •4. Able and willing to comply with the protocol.
- •5. Negative serum pregnancy test for women of childbearing potential (including pre-menopausal women who have had a tubal ligation) and for all women not meeting the definition of postmenopausal ( ≥ 12 months of amenorrhea), and who have not undergone surgical sterilization with a hysterectomy and/or bilateral oophorectomy. For all other women, documentation must be present in the medical history confirming that the patient is not of childbearing potential.
- •6. For women of childbearing potential and men with partners of childbearing potential, agreement by the patient and/or partner to use a highly effective, non-hormonal form of contraception or two effective forms of non-hormonal contraception and to continue its use for the duration of study treatment and for 7 months after the last dose of study treatment (see Section 5.2.4 in the protocol).
- •7. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- •a) Platelet count > 100,000 cells/mm3
- •b) International normalized ratio (INR) < 1.5
- •c) Absolute neutrophil count (ANC) > 1,500 cells/mm3
- •d) Hemoglobin > 9.0 g/dL. Patients are allowed to have received transfusion to achieve this level.
- •9. Liver function:
- •a) Total bilirubin ≤ 1.5 × upper limit of normal (ULN) or direct bilirubin ≤ 1.5 × ULN in patients with documented Gilbert’s syndrome.
- •b) Serum glutamic oxaloacetic transaminase (SGOT)/aspartate transaminase (AST) and serum glutamic pyruvic transaminase (SGPT)/alanine transaminase (ALT) ≤ 2.5 × ULN.
- •c) Alkaline phosphatase ≤ 2.5 × ULN. In patients with bone metastases: alkaline phosphatase ≤ 5 × ULN.
- •d) Evidence of stable liver function during the month prior to enrollment with liver function test (LFT) fluctuations not exceeding 2.5 × ULN (for AST, ALT) and 1.5 × ULN (for total bilirubin).
- •10. Renal function:
- •a) Serum creatinine of < 177 μmol/L or calculated creatinine clearance (CL) > 50 mL/min. If urine dipstick for proteinuria is ≥ 2+ at baseline, the patient must undergo 24-hour urine collection and demonstrate ≤ 1 g of protein/24 hours.
- •11. Cardiac function:
- •a) Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan.
- •12. Life expectancy ≥12 weeks
- •13. Histologically or cytologically confirmed breast cancer.
- •14. HER2-positive disease, defined as IHC 3+ or ISH positive.
- •15. Tumor block or 8 slides available for retrospective central confirmation of HER2-positivity (central confirmation not necessary for enrollment).
- •16. mBC with at least one measurable lesion according to RECIST v.1.1.
- •17. Disease progression on at least one prior regimen containing trastuzumab and chemotherapy either separately or in combination.
- •18. Patients must have recovered from previous treatments
排除标准
- •1. Prior treatments before first study treatment:
- •a) Investigational therapy within ≤ 28 days or five half-lives, whichever is longer.
- •b) Hormonal therapy within 14 days.
- •c) Trastuzumab within 21 days.
- •2. Prior enrollment in a trastuzumab emtansine-containing study, regardless of whether the patient received trastuzumab emtansine.
- •3. Prior treatment with capecitabine.
- •4. History of severe or unexpected reactions to fluoropyrimidine or known hypersensitivity to fluorouracil.
- •5. Related capecitabine contraindications:
- •a) Treatment with sorivudine or its chemically-related analogs, such as brivudine.
- •b) Rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- •c) Signs or symptoms suggesting that the patient has dihydropyrimidine dehydrogenase (DPD) deficiency.
- •6. History of intolerance (including Grade 3 or 4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins or any component of the product.
- •7. History of exposure to the following cumulative doses of anthracyclines:
- •a) Doxorubicin or liposomal doxorubicin > 500 mg/m2.
- •b) Epirubicin > 900 mg/m2.
- •c) Mitoxantrone > 120 mg/m2
- •d) If another anthracycline, or more than one anthracycline, has been used, the cumulative dose must not exceed the equivalent of 500 mg/m2 doxorubicin.
- •8. Brain metastases that are symptomatic, or require any radiation, surgery, or steroid therapy to control symptoms within 28 days before first study drug administration.
- •9. Current peripheral neuropathy of Grade ≥ 3 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.0.
- •10. History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with a similar outcome as those mentioned above.
- •11. Current unstable ventricular arrhythmia requiring treatment.
- •12. History of symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] Classes II−IV).
- •13. History of myocardial infarction or unstable angina within 6 months prior to first study drug administration.
- •14. History of a decrease in LVEF to < 40% or symptomatic CHF with previous trastuzumab treatment.
研究者
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