KCT0003346招募中未知
A Phase II Randomized Study of Palbociclib in combination with Exemestane plus GnRH agonist versus Capecitabine in Premenopausal Women with Hormone Receptor-Positive Metastatic Breast Cancer
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 182
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- Female
入选标准
- •1) A histologically proven metastatic breast cancer patient with measurable or evaluable lesion
- •2) Diagnosis of stage 4 breast cancer (de novo) or recurrence after metastatic breast cancer for cure: metastatic breast cancer is not only distant metastasis but locally advanced state Also included.
- •3)age = 19 years
- •4)ECOG performance status 0 – 2
- •5) HER-2 negative breast cancer (immunohistochemical staining (IHC score: 0-1 or 2) with negative HER2-SISH (or FISH, CISH) test) and hormone receptor positive breast cancer (ER) positive or progesterone receptor (PgR) -positive breast cancer in IHC (IHC)
- •6) Women before menopause. Premenopausal status is defined as one of the following:
- •A. If you have had a last menstrual period within the last 12 months
- •B. Serum FSH should be below 40 IU / l if tamoxifen is used within 3 months.
- •C. For amenorrhea induced by chemotherapy, serum FSH should be below 40 IU / l.
- •7) Patients may participate in this clinical trial if they have the following history of treatment.
- •However, one of the two items A and B must be included.
- •A. Preceding treatment for metastatic breast cancer of stage 4 diagnosed at the time of diagnosis for confirmed for the progression of the disease after primary cytotoxic chemotherapy.
- •B. Pre-treatment for metastatic breast cancer diagnosed at 4 stages at the time of diagnosis, allowing progression of disease after tamoxifen or Goserelin treatment. (However, recurrent metastatic breast cancer, during the adjuvant hormone therapy, or even after the end of treatment is allowed to recur)
- •C. For patients with recurrent metastatic breast cancer, patients with a history of previous or previous chemotherapy and those older than one year are eligible for this study.
- •8) If there is no possibility of pregnancy, and there is a negative result in urine or blood b-HCG test.
- •9) Adequate bone marrow function (= ANC 1,500/ul, = platelet 100,000/ul, = Hemoglobin 9.0 g/dl)
- •10) Adequate renal function (= serum creatinine 1.5 mg/dl or CCr = 50 ml/min)
- •11) Adequate liver function (= serum bilirubin 2.0 mg/dl, = AST/ALT x 3 upper normal limit)
- •12) Patients who were already established on bisphosphonate therapy may continue on bisphosphonates.
- •13) Patients agreed to use effective contraception or not of childbearing potential
- •14) Written informed consent
- •15) Signed informed consent of biomarker analysis
排除标准
- •1)Postmenopausal women
- •2)Serious uncontrolled intercurrent infections
- •3)Serious medical and psychiatric illnesses not controlled including active heart disease within 6 months of myocardial infarction, angina, uncontrolled arrhythmia
- •4)Pregnancy or breast feeding
- •5)Second primary malignancy(except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or resected thyroid papillary carcinoma or other malignancy treated at least 5 years previously with no evidence of recurrence)
- •6)Patients has received previous aromatase inhibitors and/or exemestane in the metastatic setting
- •7)Patients has received previous treatment with CDK 4/6 inhibitors, PIK3CA inhibitor. MTOR inhibitor or capecitabine
- •8) Symptomatic visceral metastasis : lymphangitic lung metastasis and/or hepatic metastasis
- •9)Known CNS metastases in spite of treated and stable
- •10) Clinically significant history of liver disease, current active abuse of alcohol or known active infection with hepatitis B virus or hepatitis C virus
- •A. However, if HBsAg (Hepatitis B surface antigen) is positive, it can be registered only when taking appropriate anti-viral agent.
- •B. In the case of HCV seropositive, only HCV RNA test results are negative.
- •11)History of QT prolongation, torsade de pointes, QTc = 480msec, long or short QT syndrome
- •12)Immunodeficiency patients or HIV infection
- •13)Unable taking oral pill
- •14)Therapeutic radiation therapy within 4 weeks of the study or palliative radiation therapy within 2 weeks of the study
- •15)Use of any investigational drug within 4 weeks of the study (except hormone therapy)
- •16)Treatment with chemotherapy within 3 weeks of the study and any endocrine therapy within 2 weeks
研究者
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