Irinotecan/Capecitabine Versus Capecitabine in Patients Treated With A/T for HER2 Negative Metastatic Breast Cancer (PROCEED)
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Purpose
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 survival in metastatic breast cancer patients previously treated with anthracycline and taxane.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Breast Cancer |
Drug: Irinotecan, Capecitabine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase III Multicenter Randomized Open-label Study of Irinotecan Plus Capecitabine Versus Capecitabine in Patients Previously Treated With Anthracycline and Taxane for HER2 Negative Metastatic Breast Cancer[PROCEED] |
- Progression free survival (PFS) [ Time Frame: The analysis for reporting the final treatment results will be undertaken when each patient has been potentially followed for a minimum of 12 months ] [ Designated as safety issue: No ]Day between the date of enrollment to the date of disease progression or death
- Objective response rate Overall survival (OS) Toxicity Quality of life (QoL) Pharmacogenomic study of irinotecan and capecitabine [ Time Frame: The analysis for reporting the final treatment results will be undertaken when each patient has been potentially followed for a minimum of 12 months ] [ Designated as safety issue: Yes ]Objective response rate Overall survival (OS) Toxicity Quality of life (QoL) Pharmacogenomic study of irinotecan and capecitabine
| Estimated Enrollment: | 222 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Capecitabine alone arm
X arm
|
|
| Experimental: Irinotecan plus capecitabine arm |
Drug: Irinotecan, Capecitabine
Irinotecan 80 mg/m2, day 1 and 8, every 3 weeks + capecitabine 1000 mg/m2, BID, day 1-14, every 3 weeks Other Name: IX arm
|
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, abdomen CT and bone scan performed within 28 days prior to start of treatment.
- Capecitabine alone arm: 1250 mg/m2, BID, day 1-14, every 3 weeks
- Irinotecan plus capecitabine arm : Irinotecan 80 mg/m2, day 1 and 8, every 3 weeks + capecitabine 1000 mg/m2, BID, day 1-14, every 3 weeks.
Randomization will be done using a random block size permutation method and stratified based on : hormone receptor status (negative vs. positive), first line vs. more than second lines, visceral metastasis (negative vs. positive).
Treatment will continue until disease progression, death, or discontinuation due to side effects of drugs or refusal by patients.
The primary objective of this study is to estimate the PFS of capecitabine and irinotecan in patients with anthracycline and taxane- pretreated metastatic breast cancer, which will be estimated by the Kaplan-Meier method and compared by log-rank test. Overall survival will be also estimated by same method. The secondary statistical analysis consisting of an estimation of the complete and partial response rates and response rates of the treatment will be calculated as the ratio of the number of complete and partial responders to the total number of evaluable patients and toxicity profile, which will be estimated as the ratio of the number of occurrence to the total number of evaluable patients. A 95% confidence interval for the response rate is computed based on the binomial distribution function. The analysis for reporting the final treatment results will be undertaken when each patient has been potentially followed for a minimum of 12 months. The overall survival and progression free survival, and their respective medians will be estimated with 95% confidence intervals.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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)
Contacts and Locations| Contact: Jungsil Ro | +82-31-920-1610 | jungsro@ncc.re.kr |
| Contact: Inhae Park | +82-31-920-1680 | parkih@ncc.re.kr |
| Korea, Republic of | |
| National Cancer Center | Recruiting |
| Goyang-si, Gyeonggi-do, Korea, Republic of | |
| Contact: Jungsil Ro +82-31-920-1610 jungsro@ncc.re.kr | |
| Principal Investigator: Jungsil Ro | |
| Principal Investigator: | Jungsil Ro | National Cencer Center, Korea |
More Information
No publications provided
| Responsible Party: | Jungsil Ro, Chief, Center for Clinical Trials, National Cancer Center, Korea, National Cancer Center, Korea |
| ClinicalTrials.gov Identifier: | NCT01501669 History of Changes |
| Other Study ID Numbers: | NCCCTS-11-536 |
| Study First Received: | December 27, 2011 |
| Last Updated: | July 17, 2012 |
| Health Authority: | South Korea: Institutional Review Board South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by National Cancer Center, Korea:
|
irinotecan capecitabine metastatic breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Irinotecan Capecitabine Fluorouracil Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 19, 2013