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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01501669
• Date of registration: 27/12/2011
• Prospective Registration: No
• Primary sponsor: National Cancer Center, Korea
• Public title: Irinotecan/Capecitabine Versus Capecitabine in Patients Treated With A/T for HER2 Negative Metastatic Breast Cancer PROCEED
• Scientific 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]
• Date of first enrolment: June 2011
• Target sample size: 222
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01501669
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Korea, Republic of

Contacts

• Name: Jungsil Ro
• Affiliation: National Cencer Center, Korea

• Name: Jungsil Ro

• Name: Jungsil Ro

Key inclusion & exclusion criteria

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)



Age minimum: 20 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Metastatic Breast Cancer

Intervention(s)

Drug: Irinotecan, Capecitabine

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

Secondary ID(s)

NCCCTS-11-536

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Inha University Hospital

Samsung Medical Center

Chung-Ang University

Korea University Anam Hospital

Asan Medical Center

Seoul National University Bundang Hospital

Seoul National University Hospital

Severance Hospital