Metastatic Breast CancerPhase 3PROCEEDNCT01501669
Irinotecan/Capecitabine Versus Capecitabine in Patients Treated With A/T for HER2 Negative Metastatic Breast Cancer
A Phase 3 study testing Irinotecan, Capecitabine in people with Metastatic Breast Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Irinotecan, Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2011to Feb 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center
Goyang-si, Gyeonggi-do
Jungsil Ro, +82-31-920-1610, jungsro@ncc.re.kr
Jungsil Ro
About this study
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]
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.
Read the 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.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Irinotecan, Capecitabine
- Keywords
- irinotecan, capecitabine, metastatic breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan, CapecitabineDrug
Also called IX arm
Irinotecan 80 mg/m2, day 1 and 8, every 3 weeks
+ capecitabine 1000 mg/m2, BID, day 1-14, every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine alone arm | No intervention | X arm |
| Irinotecan plus capecitabine arm | Experimental | Not described Receives: Drug: Irinotecan, Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Day between the date of enrollment to the date of disease progression or death
Measured: 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
Objective response rate Overall survival (OS) Toxicity Quality of life (QoL) Pharmacogenomic study of irinotecan and capecitabine
Measured: The analysis for reporting the final treatment results will be undertaken when each patient has been potentially followed for a minimum of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startJun 2011
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- 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
- Responsible party
- Principal investigator, Jungsil Ro, National Cancer Center, Korea
- Investigators
- Jungsil Ro, Principal investigator, National Cencer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501669
- Sponsor's protocol ID
- NCCCTS-11-536
- Acronym
- PROCEED
- Status last verified
- Jul 2012
- First submitted
- 27 Dec 2011
- Last updated
- 18 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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]
- ClinicalTrials.gov ID
- NCT01501669
- Acronym / sponsor ID
- PROCEED / NCCCTS-11-536
- Conditions
- Metastatic Breast Cancer
- Keywords
- irinotecan, capecitabine, metastatic breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- 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
- Study start
- Jun 2011
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 29 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capecitabine alone arm | No intervention | –X arm |
| Irinotecan plus capecitabine arm | Experimental | Drug: Irinotecan, Capecitabine |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irinotecan, CapecitabineAlso: IX armIrinotecan 80 mg/m2, day 1 and 8, every 3 weeks + capecitabine 1000 mg/m2, BID, day 1-14, every 3 weeks | Drug | Irinotecan plus capecitabine arm |
Primary outcome
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
Day between the date of enrollment to the date of disease progression or death
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jungsil Ro principal investigator
National Cencer Center, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Irinotecan, Capecitabine in people with Metastatic Breast Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jungsil Ro (+82-31-920-1610, jungsro@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2012.