Observational Program of Caelyx in MBC - Prevention and Treatment of PPE and Infusion Reactions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 167
- 主要终点
- Number of Participants With Infusion Reactions (IR)
研究概览
简要总结
This is a study to evaluate the safety and tolerability of Caelyx used for the treatment of metastatic breast cancer (MBC), focusing on infusion reaction and palmar-plantar erythrodysesthesia (PPE).
详细描述
Patients selected by investigator according to clinical routine
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with metastatic breast cancer
排除标准
- •History of hypersensitivity to Caelyx or its components
- •Women who are pregnant or breast-feeding
- •Patients with severe myelosuppression
研究组 & 干预措施
Pegylated Liposomal Doxorubicin
Subjects with metastatic breast cancer
干预措施: Pegylated Liposomal Doxorubicin (Drug)
结局指标
主要结局
Number of Participants With Infusion Reactions (IR)
时间窗: Day 1 up to Week 24
Infusion reaction was defined as an allergic reaction or anaphylactoid reaction characterized by shortness of breath, hypotension, back pain, chest pain, chills, flush, sweating, fever, nausea, dizziness, rash, pruritis, or tachycardia.
Percent of Participants Taking Premedication for Prevention of IR
时间窗: Day 1, immediately prior to receiving first dose of pegylated liposomal doxorubicin
Premedications for prevention of IR included corticosteroids, serotonin-3 receptor antagonists (anti-emetics), histamine-1 receptor blockers, and histamine-2 receptor blockers.
Number of Participants With Pre-existing Allergic Conditions Who Experienced an IR
时间窗: Cycles 1 & 3 (Week 4 & Week 12)
Allergic conditions included food allergies, drug allergies, allergic rhinitis, histamine allergy, neurodermatitis, and chronic idiopathic urticaria.
Number of Occurrences of Palmar-plantar Erythrodysesthesia (PPE)
时间窗: Up to 24 weeks
PPE was defined as a dermatological adverse event characterized by swelling, pain, edema, erythema, desquamation, that may have ultimately resulted in fissuring and ulceration, involving fingers, toes, palms, plantar aspects of the feet, and other pressure-sensitive areas of the skin.
Number of Times Premedications Were Given for Prevention of PPE
时间窗: Day 1 up to 24 weeks
Pre-medications given included oral dexamethasone, vitamin B6, and other not clearly defined medications.
次要结局
- Number of Participants With Complete Response (CR) or Partial Response (PR)(Day 1 up to 24 weeks)