An Open-Label, Phase II Study of Weekly ABI-007 as First Line Therapy for Patients With Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Celgene
- 入组人数
- 123
- 试验地点
- 14
- 主要终点
- Percentage of Participants With Objective Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Based on Investigator and Independent Reviewers
研究概览
简要总结
The purpose of this study is to determine the toxicity and anti-tumor activity of nab-paclitaxel 100mg/m^2 administered weekly in a 4-week cycle as first line therapy to patients with metastatic breast cancer who received taxanes as part of their adjuvant therapy and patients who did not receive taxanes as part of their adjuvant therapy.
详细描述
This is an open-label, phase II study to determine the toxicity and antitumor activity of ABI-007 100 mg/m2 administered weekly for 3 weeks followed by a rest week (4-week cycle) as first line therapy to patients with metastatic breast cancer in the following 2 cohorts: Patients who have received a taxane as part of their adjuvant therapy, and patients who did not receive a taxane as part of their adjuvant therapy. Patients will be assessed for antitumor response every 8 weeks.
The last subject received study treatment 11DEC2012. The study was terminated on 31 May 2013 via a notification letter to all investigators on 14 May 2013.
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
- •Females with pathologically confirmed adenocarcinoma of the breast.
- •No prior chemotherapy for metastatic breast cancer
- •At least 12 months between completion of adjuvant chemotherapy and the diagnosis of metastatic disease
- •Stage IV disease
- •Measurable disease (must be equal or greater to 2.0 cm using conventional Computed Tomography (CT) or equal or greater to 1.0 cm using spiral CT except for pulmonary lesions that are well documented on conventional CT scan which must be equal or greater than 1.0 cm)
- •At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal or there must be radiologic or clinical exam proof of progressive disease within the radiation portal
- •At least 4 weeks since major surgery, with full recovery
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Age equal or greater to 18
- •Patients has the following blood counts at Baseline:
- •Absolute Neutrophil Count (ANC) equal or greater to 1.5 x 10^9 cells/L
- •Platelets equal or greater to 100 x 10^9 cells/L
- •Hemoglobin (Hgb) equal or greater to 90 grams/L
- •Patients has the following blood chemistry levels at Baseline:
- •Aspartate aminotransferase (AST) Serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT) serum glutamic:pyruvic transaminase (SGPT)less than or equal to 2.5x upper limit of normal range (ULN);
- •total bilirubin normal (unless bilirubin elevation is due to Gilbert's (Disease);
- •alkaline phosphatase less than or equal 2.5x ULN (unless bone metastasis is present in the absence of liver metastasis);
- •Creatinine less than or equal to 1.5mg/dL
- •Current sensory neuropathy Grade 0 or 1 by Breast Cancer Index (BCI) Common Toxicity Criteria Adverse Events (CTCAE)
- •If female of childbearing potential, pregnancy test is negative (within 72 hours of the first dose of study drug).
- •If fertile, the patient agrees to use an effective method of contraception to avoid pregnancy for the duration of the study
- •Patient is able to supply unstained slides or 1 tumor block of her primary breast tumor or a biopsy of a current site of metastasis for Secreted protein acidic and rich in cysteine (SPARC) analysis
- •Informed consent has been obtained
排除标准
- •Concurrent immunotherapy or hormonal therapy (other than Herceptin) for breast cancer
- •Parenchymal brain metastases, unless documented to be clinically and radiographically stable for at least 6 months after treatment
- •Serious intercurrent medical or psychiatric illness, including serious active infection
- •History of class II-IV congestive heart failure
- •History of other malignancy within the last 5 years which could affect the diagnoses or assessment of breast cancer, with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- •Patients who have received an investigational drug within the previous 3 weeks
- •Patient is currently enrolled in a different clinical study in which investigational procedures are performed or investigational therapies are administered. Also a patient may not enroll in such clinical trials while participating in this study.
- •Pregnant or nursing women
- •Patients with prior hypersensitivity to Taxol or Taxotere
研究组 & 干预措施
ABI-007
100 mg/m^2 ABI-007 was administered by intravenous (IV) infusion over 30 minutes weekly for 3 weeks followed by 1 week rest. Therapy continued until disease progression or unacceptable toxicity.
干预措施: ABI-007 (Drug)
结局指标
主要结局
Percentage of Participants With Objective Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Based on Investigator and Independent Reviewers
时间窗: Every 8 weeks from study start until disease progression; Up to 61 months
Overall response rate (ORR) is complete response (CR) + partial response (PR). Complete response (CR): The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Disappearance of all non-target lesions. The normalization of tumor marker level confirmed at least 4 weeks after initial documentation. Partial response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits
次要结局
- Progression-free Survival (PFS)(Study start until disease progression, death, or up to data cut off of 31 May 2013; up to 61 months)
- Percentage of Participants With Disease Control(Every 8 weeks from study start until disease progression; Up to 61 months)
- Duration of Response Based on Independent Reviewer Assessment(Initial response until disease progression; or until data cut off 31 May 2013; up to 61 months)
- Duration of Response Based on Investigator Assessment(Initial response until disease progression; or until data cut off 31 May 2013; up to 61 months)
- Patient Survival(Study start until death, or until data cut-off 31 May 2013; up to 61 months)
- Number of Participants Experiencing Dose Reductions, Interruptions, or Dose Delays of Study Drug(Day 1 of study drug to Day 940; data cut off 31 May 2013)
- Number of Participants With Treatment-Emergent Adverse Events(Day 1 to Day 940)