Capecitabine in Combination With Bendamustine in Women With Pretreated Locally Advanced or Metastatic Her2-negative Breast Cancer, a Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 8
- 主要终点
- Efficacy of capecitabine + bendamustine combination regimen
研究概览
简要总结
Patients with pretreated, Her2-negative, advanced breast cancer will receive chemotherapy with capecitabine and bendamustine for a maximum of eight cycles and afterwards capecitabine alone until disease progression or unacceptable toxic effects. Safety assessments will be conducted in 3-weekly intervals, efficacy assessments (CT or MRI) will be conducted every 9 weeks.
Aim of this study is to determine whether treatment with capecitabine in combination with bendamustine is efficacious and safe.
详细描述
40 eligible patients will be enrolled. A two-stage design efficacy and safety of bendamustine and capecitabine will be evaluated following recruitment of the first 20 patients. Upon favorable results a further 20 patients will be recruited to reach the target population of 40 evaluable patients.
Pretreatment for eligible patients must include anthracyclines and/or taxanes.
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
- •Signed informed consent
- •Female patients, age ≥ 18 years (women of childbearing potential must have a negative pregnancy test at screening and must use effective contraception)
- •Advanced or metastatic Her2-negative breast cancer, histologically confirmed
- •At least one measurable lesion according to RECIST criteria (Version 1.1)
- •Documented disease progression
- •Patients with progression after anthracycline and/or taxane treatment(palliative or adjuvant)
- •Life expectancy of at least 12 weeks
- •Performance status 0-2
- •Hematologic:
- •ANC (absolute neutrophil count) ≥ 1.5 x 109/L
- •Hemoglobin ≥ 9 g/dL
- •Platelets ≥ 100 x 109/L
- •Liver Function:
- •Albumin ≥ 2.5 g/dL
- •Serum bilirubin ≤ 2 mg/dL
- •AST (Aspartate aminotransferase) and ALT (Alanine aminotransferase) ≤ 3 x ULN (Upper limit of Normal) without liver metastases
- •5 x ULN if documented liver metastases
- •Renal Function:
- •Serum Creatinine ≤ 1.5 mg/dL OR Calculated Creatinine Clearance ≥ 40 mL/min
排除标准
- •Pregnant or lactating women
- •Serious medical or psychiatric disorders that would interfere with the patient's safety or informed consent
- •Radiation of the target lesion within the last 4 weeks
- •Active bacterial, viral or fungal infection
- •Patients with clinically apparent brain metastases
- •Known Positivity for HIV
- •Positivity for Hepatitis B or C
- •History of other malignancy; patients who have been disease-free for 5 years or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
- •Concurrent cancer therapy (chemotherapy, immunotherapy, antihormonal or biologic therapy) or concurrent treatment with an investigational drug
- •Antihormonal therapy must have been discontinued prior to start of treatment (if possible at least 3 weeks before)
- •Known hypersensitivity to the study drugs capecitabine and bendamustine or their excipients
- •Pretreatment with capecitabine (pretreatment with infusional 5-FU (Fluorouracil) in the adjuvant or neoadjuvant setting is allowed) or bendamustine
- •Treatment with sorivudine or derivates e.g. brivudin (Mevir©) within the last 4 weeks before and during study treatment with capecitabine
研究组 & 干预措施
Capecitabine and Bendamustine
Capecitabine will be dosed at 1000mg/m2 twice daily for 14 days, followed by a 7-day rest period for a total cycle time of 21 days (until disease progression or unacceptable toxic effects).
Bendamustine 80mg/m2 will be administered on day 1 and 8 of a three week cycle (for a maximum of eight cycles).
Eligible patients will receive capecitabine in combination with bendamustine for a maximum of eight cycles and afterwards capecitabine mono will be continued until disease progression or unacceptable toxic effects. Safety assessments will be conducted in 3-weekly intervals; efficacy assessments will be conducted every 9 weeks.
干预措施: Capecitabine (Drug)
Capecitabine and Bendamustine
Capecitabine will be dosed at 1000mg/m2 twice daily for 14 days, followed by a 7-day rest period for a total cycle time of 21 days (until disease progression or unacceptable toxic effects).
Bendamustine 80mg/m2 will be administered on day 1 and 8 of a three week cycle (for a maximum of eight cycles).
Eligible patients will receive capecitabine in combination with bendamustine for a maximum of eight cycles and afterwards capecitabine mono will be continued until disease progression or unacceptable toxic effects. Safety assessments will be conducted in 3-weekly intervals; efficacy assessments will be conducted every 9 weeks.
干预措施: Bendamustine (Drug)
结局指标
主要结局
Efficacy of capecitabine + bendamustine combination regimen
时间窗: At baseline + every 9 weeks until progression + at end of study treatment; expected study duration 3 years
Overall response rates (complete or partial response, determined by radiologic evaluation according to Response Evaluation Criteria in Solid Tumors - RECIST (Response Evaluation Criteria In Solid Tumors) Version 1.1) The study will be stopped after 20 patients if there are fewer than four subjects with an overall response of CR (complete response) or PR (partial response). If there are at least four responses an additional 20 subjects will be enrolled and treated till a maximum of 40 subjects. The regimen is concluded to be effective if 13 or more responses out of 40 are observed at the end of the trial. The last patient is expected to enter the study in Q1 2015, following a 24 month recruitment period. Last Subject Last Visit will be at final staging after end of treatment of last patient. Follow-up after Last Subject Last Visit will be conducted according to local standard of care thereafter, and is not part of study procedures.
次要结局
- Safety profile of a combination with capecitabine and bendamustine(From treatment start until 28 days after last study treatment; expected study duration 3 years)
- Overall survival(During complete study treatment, after study treatment every 3 months until end of complete study; expected study duration 3 years)
- Predefined subgroup analysis in terms of response(Baseline + every 9 weeks until progression + at end of study treatment+every 3 months after end of treatment until end of study; expected study duration 3 years)
- Clinical benefit(Baseline + every 9 weeks until progression + at end of study treatment; expected study duration 3 years)
- Progression free survival(Baseline + every 9 weeks until progression; expected study duration 3 years)
- Quality of life(Baseline + every 9 weeks until progression + at end of study treatment; expected study duration 3 years)