NCT02613208已完成不适用
Observational and Prospective Study to Develop Predictive and Prognostic Tools for Optimizing Therapy With Bevacizumab Frontline Cancer Therapy in Patients With Metastatic HER 2-Negative and Aggressive Disease Criteria
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 25
- 主要终点
- Percentage of Participants With Clinical Benefit
研究概览
简要总结
This multicenter, observational, prospective study will identify a powerful and easy predictive/prognostic marker to use with participants under bevacizumab.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with HER2-negative metastatic breast cancer. Mandatory to have the HER2/estrogen receptor (ER)/progesterone receptor (PR) status
- •Participant who met criteria for first-line treatment with chemotherapy plus bevacizumab (standard doses) by local, regional or national guidelines or authorities
- •Participants with measurable disease (RECIST criteria v1.1) or participants with no measurable but assessable disease
- •Molecular phenotype as triple negative metastatic breast cancer; and ER-positive tumors need to fulfill at least one of the two clinical criteria: metastatic relapse on adjuvant endocrine therapy or progression to at least one prior line of endocrine therapy for advanced disease; or aggressive disease criteria (at least two criteria): taxane based regimen in the (neo) adjuvant setting; metastatic relapse within 2 years from the end of chemotherapy for early breast cancer; liver metastasis; three or more organs with metastatic involvement; symptomatic visceral disease
- •Eastern Cooperative Oncology Group (ECOG) 0-2
排除标准
- •Participant has received prior chemotherapy for metastatic disease
- •Participant requiring major/minor surgery within 3 weeks prior to administration of the first dose of study treatment
- •Participant has received an investigational therapy within 4 weeks prior to study entry
- •Participant has known symptomatic brain metastases
- •Participant with non-measurable or assessable disease: exclusive blastic bone disease; pleural, pericardial or abdominal effusion as only evidence of disease
- •Participant in chronic daily treatment with corticosteroids (doses greater than [>]10 milligrams per day [mg/day] of methylprednisolone or equivalent), except inhaled steroids
- •Pregnant or breastfeeding participant
- •Women of childbearing potential who are not using hormonal contraceptives or highly effective birth control during the study
- •Participant has an active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
- •Participant with significant renal, hematological or liver function alteration according to investigator's criteria
- •Participant has serious medical risk factors involving any of the major organ systems
研究组 & 干预措施
Participants With Metastatic Breast Cancer
Participants with metastatic breast cancer receiving bevacizumab in combination with paclitaxel, will be observed for treatment responses for up to 18 months from the start of treatment.
干预措施: Bevacizumab (Drug)
Participants With Metastatic Breast Cancer
Participants with metastatic breast cancer receiving bevacizumab in combination with paclitaxel, will be observed for treatment responses for up to 18 months from the start of treatment.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Percentage of Participants With Clinical Benefit
时间窗: During follow-up (up to 18 months)
Clinical benefit was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). Clinical benefit is defined as partial or complete response as well as tumor stabilization for up to 24 weeks. Results for clinical benefit were reported for 2 groups based on Circulating Tumor Cells (CTC) Levels. The Sensitive group had CTC levels \<5 (\<5 CTCs in one of the two determinations) and Resistant group had CTC ≥5 (≥ 5 CTCs in the two determinations).
次要结局
- Percentage of Participants With Overall Response as Assessed Using RECIST v1.1(From Baseline up to end of study (up to 18 months))
- Progression Free Survival (PFS) as Assessed Using RECIST v1.1(From Baseline up to end of study (up to 18 months))
- Mean CTC Count Levels(Baseline (within 21 days prior to Day 1 Cycle 1 [Cycle length = 28 days]))
- Overall Survival(From Baseline up to end of study (up to 18 months))
- Percentage of Participants With Adverse Events of Toxicity Grading 3 and/or 4(From Baseline up to end of study (up to 18 months))
- Optimal Cut-off for Clinical Benefit(Baseline (within 21 days prior to Day 1 Cycle 1), 7 days prior to Day 1 Cycle 3 (Cycle length = 28 days))
- Percentage of Participants With Overall Response (OR) as Assessed Using RECIST v1. in Prognostic Groups(Baseline (within 21 days prior to Day 1 Cycle 1), 7 days prior to Day 1 Cycle 3 (Cycle length = 28 days))
- PFS as Assessed Using RECIST v1. in Prognostic Groups(From Baseline up to end of study (up to 18 months))
- Mean Carcinoembryonic Antigen (CEA) Levels(Baseline (within 21 days prior to Day 1 Cycle 1 [Cycle length = 28 days]))
- Mean Biomarker Cancer Antigen 15.3 (CA 15.3) Level(Baseline (within 21 days prior to Day 1 Cycle 1 [Cycle length = 28 days]))
研究者
研究点 (25)
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