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

Primary Purpose

Metastatic Breast Cancer

Status

Unknown status

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Irinotecan, Capecitabine

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring irinotecan, capecitabine, metastatic breast cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

National Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Capecitabine alone arm

Irinotecan plus capecitabine arm

Arm Description

X arm

Outcomes

Primary Outcome Measures

Progression free survival (PFS)

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01501669

First Posted

December 27, 2011

Last Updated

July 17, 2012

Sponsor

National Cancer Center, Korea

Collaborators

Asan Medical Center, Chung-Ang University, Inha University Hospital, Korea University Anam Hospital, Samsung Medical Center, Severance Hospital, Seoul National University Hospital, Seoul National University Bundang Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01501669

Brief Title

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

Acronym

PROCEED

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]

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Unknown status

Study Start Date

June 2011 (undefined)

Primary Completion Date

February 2014 (Anticipated)

Study Completion Date

February 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Cancer Center, Korea

Collaborators

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Breast Cancer

Keywords

irinotecan, capecitabine, metastatic breast cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

222 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Capecitabine alone arm

Arm Type

No Intervention

Arm Description

X arm

Arm Title

Irinotecan plus capecitabine arm

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Irinotecan, Capecitabine

Other Intervention Name(s)

IX arm

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression free survival (PFS)

Description

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

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 Measure Information:

Title

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

Description

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jungsil Ro

Phone

+82-31-920-1610

jungsro@ncc.re.kr

First Name & Middle Initial & Last Name or Official Title & Degree

Inhae Park

Phone

+82-31-920-1680

parkih@ncc.re.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jungsil Ro

Organizational Affiliation

National Cencer Center, Korea

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Center

City

Goyang-si

State/Province

Gyeonggi-do

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jungsil Ro

Phone

+82-31-920-1610

jungsro@ncc.re.kr

First Name & Middle Initial & Last Name & Degree

Jungsil Ro

12. IPD Sharing Statement

Learn more about this trial

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

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