Irinotecan/Capecitabine Versus Capecitabine in Patients Treated With A/T for HER2 Negative Metastatic Breast Cancer

NCT01501669 | Unknown Phase 3

• 1 other identifier: NCCCTS-11-536
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

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 survival in metastatic breast cancer patients previously treated with anthracycline and taxane.

Conditions

Metastatic Breast Cancer

Keywords

irinotecan; capecitabine; metastatic breast cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  Day between the date of enrollment to the date of disease progression or death

  The analysis for reporting the final treatment results will be undertaken when each patient has been potentially followed for a minimum of 12 months

Secondary Outcomes (1)

• Objective response rate Overall survival (OS) Toxicity Quality of life (QoL) Pharmacogenomic study of irinotecan and capecitabine

  The analysis for reporting the final treatment results will be undertaken when each patient has been potentially followed for a minimum of 12 months

Study Arms (2)

Capecitabine alone arm

NO INTERVENTION

X arm

Irinotecan plus capecitabine arm

EXPERIMENTAL

Drug: Irinotecan, Capecitabine

Interventions

Irinotecan, Capecitabine DRUG

Irinotecan 80 mg/m2, day 1 and 8, every 3 weeks \+ capecitabine 1000 mg/m2, BID, day 1-14, every 3 weeks

Also known as: IX arm

Irinotecan plus capecitabine arm

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Cancer Center, Korea: lead
• Asan Medical Center: collaborator
• Chung-Ang University: collaborator
• Inha University Hospital: collaborator
• Korea University Anam Hospital: collaborator
• Samsung Medical Center: collaborator
• Severance Hospital: collaborator
• Seoul National University Hospital: collaborator
• Seoul National University Bundang Hospital: collaborator

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Irinotecan; Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jungsil Ro

  National Cencer Center, Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jungsil Ro

CONTACT

+82-31-920-1610; jungsro@ncc.re.kr

Inhae Park

CONTACT

+82-31-920-1680; parkih@ncc.re.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Center for Clinical Trials, National Cancer Center, Korea

Study Record Dates

• First Submitted: December 27, 2011
• First Posted: December 29, 2011
• Study Start: June 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: July 18, 2012

Record last verified: 2012-07

Locations

KR (1)