'A Study of the Effect of First Line Treatment With Paclitaxel and Myocet in Combination With Herceptin on Overall Tumor Response in Patients With Metastatic or Locally Advanced Breast Cancer and HER2 Overexpression.'
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 69
- 主要终点
- Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to World Health Organization (WHO) Handbook for Reporting Results of Cancer Treatment
研究概览
简要总结
This study will define an optimal chemotherapy dose regimen of Myocet in combination with paclitaxel and intravenous Herceptin and will evaluate the efficacy and safety of this dose regimen in patients with metastatic or locally advanced breast cancer and HER2 overexpression. The anticipated time on study treatment is 3-12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women 18-70 years of age;
- •metastatic or locally advanced breast cancer;
- •HER2 overexpression;
- •>= 1 measurable lesion.
排除标准
- •prior treatment for advanced breast cancer;
- •prior treatment with Herceptin;
- •bone or central nervous system metastasis as the only site of disease;
- •history of another malignancy (except basal cell skin cancer and cancer in situ of the uterine cervix, and contralateral breast cancer) within 5 years of study.
研究组 & 干预措施
Trastuzumab, Myocet, Paclitaxel; Phase I
Participants received an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), over 1.5 hours during Week 1, followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression. Participants also received myocet, 40 mg/ square meter (m^2), IV, every 3 weeks, from Week 1; if no dose limiting toxicity (DLT) was observed in greater than or equal to (≥) two-thirds (2/3) of cohort for 2 treatment cycles, the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles. Participants also received paclitaxel 60 mg/ m^2, IV, once per week, from Week 19; if no DLT was observed in ≥ 2/3 of cohort for 2 treatment cycles, the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression.
干预措施: trastuzumab (Drug)
Trastuzumab, Myocet, Paclitaxel; Phase I
Participants received an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), over 1.5 hours during Week 1, followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression. Participants also received myocet, 40 mg/ square meter (m^2), IV, every 3 weeks, from Week 1; if no dose limiting toxicity (DLT) was observed in greater than or equal to (≥) two-thirds (2/3) of cohort for 2 treatment cycles, the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles. Participants also received paclitaxel 60 mg/ m^2, IV, once per week, from Week 19; if no DLT was observed in ≥ 2/3 of cohort for 2 treatment cycles, the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression.
干预措施: paclitaxel (Drug)
Trastuzumab, Myocet, Paclitaxel; Phase I
Participants received an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), over 1.5 hours during Week 1, followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression. Participants also received myocet, 40 mg/ square meter (m^2), IV, every 3 weeks, from Week 1; if no dose limiting toxicity (DLT) was observed in greater than or equal to (≥) two-thirds (2/3) of cohort for 2 treatment cycles, the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles. Participants also received paclitaxel 60 mg/ m^2, IV, once per week, from Week 19; if no DLT was observed in ≥ 2/3 of cohort for 2 treatment cycles, the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression.
干预措施: Myocet (Drug)
Trastuzumab, Myocet, Paclitaxel; Phase II
Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours during Week 1, followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression. Participants also received myocet, 50 mg/m^2, IV, every 3 weeks, from Week 1 for 6 cycles. Participants also received paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
干预措施: trastuzumab (Drug)
Trastuzumab, Myocet, Paclitaxel; Phase II
Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours during Week 1, followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression. Participants also received myocet, 50 mg/m^2, IV, every 3 weeks, from Week 1 for 6 cycles. Participants also received paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
干预措施: paclitaxel (Drug)
Trastuzumab, Myocet, Paclitaxel; Phase II
Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours during Week 1, followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression. Participants also received myocet, 50 mg/m^2, IV, every 3 weeks, from Week 1 for 6 cycles. Participants also received paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
干预措施: Myocet (Drug)
结局指标
主要结局
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to World Health Organization (WHO) Handbook for Reporting Results of Cancer Treatment
时间窗: Baseline (BL), Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
For measurable disease, CR was defined as the disappearance of all clinically detectable disease determined by 2 observations not less than 4 weeks apart; and PR was defined as a 50 percent (%) decrease in the sum of the products of the 2 greatest diameters of all measurable lesions by 2 observations not less than 4 weeks apart, and no appearance of new lesions or progression of any lesion. For immeasurable disease, CR was defined as the complete disappearance of all known disease for at least 4 weeks; and PR was defined as an estimated decrease in tumor size of 50% or more for at least 4 weeks.
次要结局
- Time to Treatment Response(BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years))
- Duration of Response(BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years))
- Time to Treatment Response - Percentage of Participants With an Event(BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years))
- Time to Disease Progression(BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years))
- Time to Disease Progression - Percentage of Participants With an Event(BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years))
- Overall Survival(BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years))
- Duration of Response - Percentage of Participants With an Event(BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years))
- Time to Therapy Failure - Percentage of Participants With an Event(BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years))
- Time to Therapy Failure(BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years))
- Overall Survival (OS) - Percentage of Participants With an Event(BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years))