EUCTR2016-004482-89-DE进行中（未招募）1 期
A RANDOMIZED, OPEN-LABEL, MULTI-CENTER PHASE IV STUDY EVALUATING PALBOCICLIB PLUS ENDOCRINE TREATMENT VERSUS A CHEMOTHERAPY-BASED TREATMENT STRATEGY IN PATIENTS WITH HORMONE RECEPTOR POSITIVE / HER2 NEGATIVE METASTATIC BREAST CANCER IN A REAL WORLD SETTING. - PADMA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
- All
入选标准
- •1. Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, willingness and ability to complete collection of data via study mobile must be obtained and documented according to the local regulatory requirements.
- •2. Female or male patients.
- •3. Age = 18 years old.
- •4. Metastatic invasive hormone receptor positive and HER2 negative breast cancer (histologically confirmed).
- •5. Patients who in the opinion of the treating physician are candidates suitable for randomization for mono-chemotherapy treatment, that has either an approved label in Europe and/or is supported by guidelines for the treatment of first-line advanced BC, which are based on evidence on safety and efficacy in this setting.
- •6. Symptomatic or asymptomatic metastatic breast cancer.
- •7. Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE version 4.0 grade = 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion).
- •8. Life-expectancy > 6 months.
- •9. For female patients: The patients need to be either A) of non-childbearing potential (documented postmenopausal or post hysterectomy) B) childbearing potential with negative serum or urinary pregnancy test (in this case patients need to use highly effective non-hormonal contraceptive methods).
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •1. Indication for poly-chemotherapy or single-agent endocrine therapy only or bevacizumab.
- •2. Asymptomatic oligometastases of the bone as the only site of metastatic disease.
- •3. Uncontrolled/untreated central nervous system lesions.
- •4. Patients who received treatment for metastatic/relapsed breast cancer.
- •5. Inadequate organ function as per physician’s assessment immediate prior to randomization.
- •6. Treatment with preparations containing St. John´s Wort within the last 7 days prior to randomization and/or concurrent use.
- •7. Known severe hypersensitivity reactions to compounds or excipients similar to palbociclib, planned chemotherapy or planned endocrine therapy.
- •8. Existing contraindication against the use of palbociclib, planned chemotherapy or planned endocrine therapy.
- •9. Patients with hereditary problems of galactose intolerance, the Lapp lactase deficiency, and glucose-galactose malabsorption.
- •10. Female patients: pregnancy or lactation at the time of randomization or intention to become pregnant during the study and up to six months after treatment. Male patients: Intention to beget a child during the study and up to six months after treatment.
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