EUCTR2014-000842-30-IT进行中（未招募）1 期
Caelyx¿ as Adjuvant Treatment in Early Stage Luminal B Breast Cancer: a feasibility Phase II Trial - Not applicable
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 63
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
- 性别
- Female
入选标准
- •Operable histologically confirmed breast cancer
- •Luminal B HER2-negative (ER positive, HER2 negative, and at least one of the following: Ki-67 ‘high’ (=20%) or PgR ‘negative or low’) or Luminal B HER2-positive (ER positive, HER2 over-expressed or amplified, any Ki-67, any PgR)
- •Early-stage (pT1-3; any nodal status)
- •Candidate to adjuvant chemotherapy and endocrine therapy
- •The tumor must be confined to the breast and axillary nodes without detected metastases elsewhere
- •Patients with synchronous (diagnosed histologically within 2 months) bilateral invasive breast cancer are eligible if all other criteria are met
- •Patients must have had surgery for primary breast cancer with no known clinical residual loco-regional disease
- •Margins must be negative for invasive breast cancer and DCIS
- •Patients should be start treatment as close to definitive surgery as possible (no later than 8 weeks)
- •No prior neoadjuvant or adjuvant therapy for breast cancer. Note: Radiotherapy is allowed prior to trial entry.
- •Raloxifene, tamoxifen, or other SERM must be discontinued at least 4 weeks before trial entry.
- •No hormone replacement therapy (HRT).
- •No hormonal therapy, except steroids for adrenal failure, hormones for non-breast cancer related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic.
- •No treatment with bisphosphonates, except for the treatment of osteoporosis.
- •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 43
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Patients with a history of any prior ipsilateral or contralateral invasive breast cancer.
- •Patients with previous or concomitant malignancy diagnosed within the past five years.
- •Patients with other non-malignant uncontrolled systemic diseases that would preclude trial entry in the opinion of the investigator. Specifically not eligible are patients with uncontrolled active infection, chronic infection such as active HBV or HCV
- •Patients with myocardial infarction or pulmonary embolism within 6 months prior to trial entry.
研究者
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