EUCTR2013-000173-77-BE进行中（未招募）1 期
TRIUMPH TrialA phase II TRial evalUating the Menstrual and ovarian function of young breast cancer patients treated with a cycloPHosphamide-free regimen composed of doxorubicin and paclitaxel - TRIUMPH
Institut Jules Bordet0 个研究点目标入组 50 人开始时间: 2013年8月8日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- •Patients must meet ALL of the following criteria in order to be eligible for this study:
- •1.Age = 40 years.
- •2.Eastern Cooperative Oncology Group (ECOG) performance status = 1.
- •3.Non-metastatic primary invasive carcinoma of the breast eligible for adjuvant or neoadjuvant chemotherapy.
- •4.Negative estrogen (ER) and progesterone receptor (PgR) status.
- •5.Baseline left ventricular ejection fraction (LVEF) =50% measured by an echocardiogram or MUGA.
- •6.Interested in maintaining menstrual and/or ovarian function following completion of chemotherapy.
- •7.Known HER2/neu status.
- •8.Negative pregnancy test within 14 days prior to starting chemotherapy.
- •9.Adequate hematologic, hepatic and renal function.
- •10.Signed informed consent.
- •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 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients meeting any ONE of the following criteria are not eligible for this study:
- •1.History of prior malignant disease (breast or non-breast) or non-malignant condition which was treated with chemotherapy, pelvic irradiation or any therapy that could potentially affect ovarian function.
- •2.Previous history of amenorrhea > 3 months within the last 2 years (excluding pregnancy).
- •3.Ovarian insufficiency defined as serum FSH > 20 IU/L at the local laboratory, anytime during the menstrual cycle.
- •4.Any ovarian pathology or abnormalities at the screening pelvic ultrasound, except for functional follicular cysts.
- •5.Pregnant or breastfeeding patients.
- •6.Inability or unwillingness to use effective contraception during and up to 3 months after the last dose of study medication. Effective methods include the following: non-hormonal intrauterine device, barrier method - condoms, diaphragm – also in conjugation with spermicidal jelly, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not allowed.
- •7.Concurrent use of any other cytotoxic or hormonal agent, namely GnRH agonists.
- •8.Prior pre-existing peripheral neuropathy of any cause, including diabetes mellitus, alcohol abuse, HIV infection, autoimmune and hereditary neuropathies, amyloidosis, hypothyroidism, vitamin deficiencies.
- •9.Serious cardiac illness, uncontrolled hypertension or medical condition that would affect administration of chemotherapy and compliance to study procedures.
- •10.Known sensitivity to any of the study medications.
研究者
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