Status:
UNKNOWN
Irinotecan/Capecitabine Versus Capecitabine in Patients Treated With A/T for HER2 Negative Metastatic Breast Cancer
Lead Sponsor:
National Cancer Center, Korea
Collaborating Sponsors:
Asan Medical Center
Chung-Ang University
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
20+ years
Phase:
PHASE3
Brief Summary
This study is a multicenter, randomized study, open-label, phase III study.The efficacy of irinotecan and capecitabine combination will be superior to capecitabine alone in term of progression free su...
Detailed Description
Prior to enrollment, patients will be confirmed for hormone and HER2 receptor status. Patients may have either measurable and/or evaluable metastatic lesions which are able to be assessed by chest, ab...
Eligibility Criteria
Inclusion
- Histologically confirmed stage IV or recurrent breast cancer
- HER2 negative disease, or HER2 unknown disease not eligible for anti-HER2 therapy
- ECOG performance status 0-2
- Age ≥ 20 years
- Patients who received anthracycline based chemotherapy in the (neo)adjuvant or metastatic setting and experienced disease progression on taxane based chemotherapy in the metastatic setting, or patients who experienced disease recurrence within 1 year after completion of (neo)adjuvant anthracycline and taxane based chemotherapy
- In case of patients treated with capecitabine in an adjuvant setting, disease recurrence should not be occurred within 1 year after completion of capecitabine chemotherapy
- Patients with brain metastasis can be enrolled when they don't need any treatment regarding to brain metastasis
- Previous any chemotherapy and radiotherapy should be completed at least 3 weeks before randomization- Measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 \[21\]
- Adequate hematopoietic function: absolute granulocyte count ≥ 1,500/mm3, platelet ≥ 100,000/mm3, hemoglobin ≥ 10g/mm3
- Adequate hepatic function: total bilirubin ≤ 1.5mg/dL, alkaline phosphatase(ALP) ≤ 2.5 x UNL, AST/ALT ≤ 2x UNL, or if liver function abnormalities due to underlying malignancy exists, AST/ALT ≤ 2.5 x UNL, total bilirubin ≤ 3.0mg/dL, (ALP) ≤ 5 x UNL in cases with bone metastasis; ALP ≤ 5 x UNL
- Adequate renal function : serum creatinine ≤ 1.5mg/dL
- Ability to understand and comply with protocol during study period
- Patients should sign a written informed consent before study entry
Exclusion
- Pregnant or lactating women
- Patients who receive irinotecan or capecitabine for metastatic breast cancer treatment
- Patients with HER2 positive breast cancer
- Grade 2 or greater peripheral neuropathy
- Patients with symptomatic brain metastasis
- Prior unanticipated severe reaction to fluropyrimidine therapy or known sensitivity to 5-fluorouracil
- Patients who have history of cancer other than in situ cervical cancer or non-melanotic skin cancer
- Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedure affecting absorption, uncontrolled GI disease (e.g. Crohn's disease, ulcerative colitis)
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2014
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT01501669
Start Date
June 1 2011
End Date
February 1 2014
Last Update
July 18 2012
Active Locations (1)
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1
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea