A Multi Centre, Pilot Phase II Trial Assessing the Efficacy and Safety of Bevacizumab + Gemcitabine + Carboplatin as First Line Treatment for Patients Diagnosed With Triple Negative Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
This multicenter study will assess the efficacy and safety of bevacizumab in combination with gemcitabine and cisplatin as first line treatment in participants with triple negative metastatic breast cancer. Participants will receive bevacizumab at a dose of 15 mg/kg intravenously (iv) every 3 weeks, plus gemcitabine (1000 mg/m2 iv) and carboplatin (iv to an area under curve [AUC]=2) on Days 1 and 8 of each 3-week cycle. Anticipated time on study treatment is until disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants, >/= 18 years of age
- •Metastatic breast cancer
- •Estrogen receptor-, progesterone- and human epidermal growth factor receptor 2 (HER2)-negative disease
- •Treatment-naïve for metastatic breast cancer
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Adequate hematological, renal and liver function
- •Patients should have received Anthracyclines and Taxanes in the adjuvant setting
- •Women of childbearing potential must agree to use adequate contraception (per institutional standard of care) during treatment and until 6 months after the last administration of investigational products
排除标准
- •Prior first line treatment for metastatic breast cancer
- •Central nervous system (CNS) metastasis
- •Uncontrolled hypertension (> 170/95 mmHg)
- •Evidence of bleeding diathesis, coagulopathy or hemorrhage at baseline
- •Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
- •Prior therapy with gemcitabine or carboplatin in the metastatic setting. Participants having received gemcitabine or carboplatin as part of adjuvant therapy are eligible, if recurrence was first documented >6 months after the last exposure to the drug(s)
- •Requirement of chronic use of immunosuppressive agents
- •HIV, hepatitis B or hepatitis C infection
研究组 & 干预措施
Overall Participants
Participants received a combination therapy of bevacizumab with gemcitabine plus carboplatin.
干预措施: Bevacizumab (Drug)
Overall Participants
Participants received a combination therapy of bevacizumab with gemcitabine plus carboplatin.
干预措施: Carboplatin (Drug)
Overall Participants
Participants received a combination therapy of bevacizumab with gemcitabine plus carboplatin.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: From the date of registration until the disease progression or death (up to 1541 days).
Progression free survival (PFS) was calculated in days from the date of registration until the earliest date of documented disease progression or death. The median PFS time with 95% confidence interval (CI) was estimated using Kaplan Meier method. The progression-free survival was assessed utilizing computer tomography (CT)/ magnetic resonance imaging (MRI)/bone scans and X-ray and Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1. Progression of disease is defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
次要结局
- Change From Baseline in Systolic Blood Pressure (SBP)(Baseline, Cycle 6, 12 of treatment)
- Percentage of Participants Achieving an Overall Response(From the date of registration until the disease progression or death (up to 1541 days))
- Percentage of Participants Achieving a Clinical Benefit Response (CBR)(From the date of registration until the disease progression or death (up to 1541 days))
- Number of Participants With an Adverse Event (AE)(Up to 28 days after termination of study treatment (approximately 1569 days))
- Time to Progression (TTP)(From the date of registration until the disease progression (up to 1541 days).)
- Overall Survival (OS)(From the date of registration until the disease progression or death (up to 1541 days))
- Change From Baseline to Cycle 6 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30)(Baseline, cycle 6)
- Change From Baseline in Diastolic Blood Pressure (DBP)(Baseline, Cycle 6, 12 of treatment)