Randomized, Phase 2 Study to Estimate the Effect of Prophylactic Intervention With Naproxen or Loratadine on Bone Pain in Breast Cancer Subjects Receiving Chemotherapy and Pegfilgrastim
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Bone Pain (All Grades) in Cycle 1
研究概览
简要总结
The primary objective of the study is to estimate the difference in bone pain between breast cancer patients receiving chemotherapy and pegfilgrastim and either no prophylactic intervention, prophylactic naproxen, or prophylactic loratadine.
详细描述
In this study, the investigational products are naproxen, a non-steroidal antiinflammatory drug (NSAID), and loratadine, an anti-histamine. Both agents are being investigated as prophylactic medications to reduce the incidence and/or severity of bone pain in breast cancer patients receiving adjuvant or neoadjuvant myelosuppressive chemotherapy and pegfilgrastim prophylaxis.
Pegfilgrastim treatment is used to stimulate bone marrow to produce more neutrophils to help fight infections in patients undergoing chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Prophylactic naproxen
Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
干预措施: Naproxen (Drug)
Prophylactic naproxen
Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
干预措施: Pegfilgrastim (Biological)
Prophylactic naproxen
Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
干预措施: Chemotherapy (Drug)
Prophylactic loratadine
Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
干预措施: Loratadine (Drug)
Prophylactic loratadine
Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
干预措施: Pegfilgrastim (Biological)
Prophylactic loratadine
Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
干预措施: Chemotherapy (Drug)
No prophylactic treatment
Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis.
干预措施: Pegfilgrastim (Biological)
No prophylactic treatment
Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Percentage of Participants With Bone Pain (All Grades) in Cycle 1
时间窗: Cycle 1 (approximately 4 weeks, depending on the chemotherapy dosing interval)
Bone pain data were captured as part of standard adverse event (AE) reporting.
次要结局
- Maximum Patient-reported Bone Pain by Cycle and Across Cycles(Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle))
- Percentage of Participants With Bone Pain (All Grades) by Cycle (2-4) and Across Cycles(Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval))
- Area Under the Curve (AUC) for Patient-reported Bone Pain(Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle))
- Number of Participants With Adverse Events (AEs)(From first dose of investigational product (IP, naproxen or loratidine) or first dose of pegfilgrastim (Peg), whichever occurred first, until 30 days after last dose, up to 24 weeks.)
- Percentage of Participants With Severe Bone Pain by Cycle and Across Cycles(Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval))
- Mean Patient-reported Bone Pain by Cycle and Across Cycles(Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle))