EUCTR2013-000287-29-DE进行中（未招募）1 期
EARLY PREDICTION OF EFFICACY OF ENDOCRINE THERAPY IN BREAST CANCER:PILOT STUDY AND VALIDATION WITH 18F FLUOROESTRADIOL (FES) PET/CT
niversità del Piemonte Orientale0 个研究点目标入组 400 人开始时间: 2015年1月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
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
- •Inclusion Criteria
- •- Histologically or cytologically confirmed breast cancer
- •- Metastatic disease, stage IV
- •- No prior treatments for metastatic breast cancer
- •- HER2 negative disease, as measured locally by IHC or FISH (standard clinical
- •- Endocrine-sensitive disease as evaluated locally, by ER expression at the
- •time of diagnosis on the primary tumor.
- •- Prior endocrine therapy is allowed only in the adjuvant setting
- •- Prior adjuvant/neoadjuvant chemotherapy is allowed provided it is
- •terminated at least 12 months before study entry. Adjuvant anthracyclines
- •and adjuvant taxanes are allowed.
- •- Patients progressed during or after adjuvant endocrine therapy are eligible
- •- Radiation therapy, if given and regardless of site, must be completed at least 2
- •weeks prior to randomization.
- •- Measurable or non measurable, but evaluable disease.
- •- Visceral, and/or soft tissue and/or bone metastases
- •- Eastern Cooperative Oncology Group (ECOG) performance status < 2
- •- Life expectancy > 3 months
- •- No history of other malignancies
- •- Signed written informed consent
- •- Ability to comply with the study protocol
- •- Age 18 years or older
- •- Availability of an FFPE block from the primary tumor (breast lesion) for
- •submission to central pathology review.
- •- A biopsy of metastatic lesions is recommended, if technically feasible.
- •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 220
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 220
排除标准
- •Exclusion Criteria
- •- HER-2 positive disease
- •- Use of estrogen receptor ligands, including tamoxifen, fulvestrant or estrogens,
- •during the two weeks before entry into the study
- •- Prior history of non-breast malignancy (except for adequately controlled basal
- •cell carcinoma of the skin, carcinoma in situ of the cervix, in situ carcinoma of the
- •- Brain or leptomeningeal metastases
研究者
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