Advanced/Metastatic Breast CancerPhase 2NCT00662025
Study Of Sunitinib With Capecitabine In Breast Cancer
A Phase 2 study testing Capecitabine and Sunitinib in people with Advanced/Metastatic Breast Cancer, run by Pfizer at 17 sites in Japan.
Trial summary
To evaluate efficacy, safety and pharmacokinetics of sunitinib plus Capecitabine in Japanese patients with advanced/metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Advanced/Metastatic Breast Cancer
- What is being tested?
- Capecitabine and Sunitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 17 sitesJapan
- Study dates
- Apr 2008to May 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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- or cytologically-proven diagnosis of breast adenocarcinoma that is not amenable to surgery, radiation, or combined modality therapy with curative intent
- Measurable disease as per RECIST. Measurable lesions that have been previously irradiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy.
- Prior treatment with an anthracycline and a taxane in the neoadjuvant, adjuvant or metastatic disease settings.
Who cannot join
- Histology of inflammatory carcinoma with no other measurable disease. Patients with histology of inflammatory carcinoma are allowed on study if they have measurable disease.
- Brain metastases, spinal cord compression, or carcinomatous meningitis, or leptomeningeal disease.
- Prior treatment with 5-fluorouracil (5-FU) and 5-FU derivatives such as Furtulon (5'-DFUR), Futraful/ Sunfural (tegafur), UFT/UFT-E (tegafur/uracil), TS-1 (tegafur/gimeracil/oteracil) or Mifurol (carmofur) in metastatic disease setting
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Japan17 sites
Pfizer Investigational Site
Anjo, Aichi-ken
Pfizer Investigational Site
Bunkyo-ku, Tokyo
Pfizer Investigational Site
Chiba, Chiba
Pfizer Investigational Site
Fukuoka, Fukuoka
Pfizer Investigational Site
Kagoshima, Kagoshima-ken
Pfizer Investigational Site
Koto-ku, Tokyo
Pfizer Investigational Site
Kure, Hiroshima
Pfizer Investigational Site
Kyoto, Japan
Pfizer Investigational Site
Matsuyama, Ehime
Pfizer Investigational Site
Morioka, Iwate
Pfizer Investigational Site
Nagoya, Aichi-ken
Pfizer Investigational Site
Niigata
Pfizer Investigational Site
Okazaki, Aichi-ken
Pfizer Investigational Site
Osaka, Osaka
Pfizer Investigational Site
Sakai, Osaka
Pfizer Investigational Site
Toyoake, Aichi-ken
Pfizer Investigational Site
Yokohama, Kanagawa
About this study
Official title: A Phase II Study Of Sunitinib Malate In Combination With Capecitabine In Patients With Advanced Or Metastatic Breast Cancer
To evaluate efficacy, safety and pharmacokinetics of sunitinib plus Capecitabine in Japanese patients with advanced/metastatic breast cancer.
- Conditions
- Advanced/Metastatic Breast Cancer
- Being tested
- Capecitabine, Sunitinib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Capecitabine 1000 mg/m2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
SunitinibDrug
Sunitinib 37.5 mg daily, continuous dosing
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Capecitabine; Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Objective Response Based on Data Review Committee's Assessment
Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST). CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the longest dimensions (LDs) of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.
Measured: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8.
Secondary outcomes (16)
Number of Participants With Objective Response Based on Investigator's Assessment
Number of participants with objective response based on assessment of confirmed CR or confirmed PR according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.
Measured: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study.
Number of Participants With Clinical Benefit Response (CBR) Based on Data Review Committee's Assessment
Number of participants with confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as a reference the baseline sum LD according to RECIST. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of LDs since treatment started.
Measured: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8.
Number of Subjects With CBR Based on Investigator's Assessment
Number of participants with confirmed CR, PR or SD for at least 24 weeks on study according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as a reference the baseline sum LD according to RECIST. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of LDs since treatment started.
Measured: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study.
Progression-Free Survival (PFS)
Based on Data Review Committee's Assessment. PFS is defined as the time from the start of study treatment to first documentation of objective tumor progression, or to death on study due to any cause, whichever occurred first.
Measured: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.
Time to Tumor Progression (TTP)
Based on Data Review Committee's Assessment. TTP is defined as the time from the start of study treatment to first documentation of objective tumor progression.
Measured: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.
Duration of Objective Tumor Response (DR)
Based on Data Review Committee's Assessment. DR is defined as the time from the first documentation of objective tumor response (confirmed CR or PR) to the first documentation of disease progression or to death due to cancer, whichever occurred first. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.
Measured: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.
Time to Objective Tumor Response (TTR)
Based on Data Review Committee's Assessment. TTR is defined as the time from the start of study treatment to first documentation of objective tumor response (confirmed CR or PR). CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.
Measured: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.
Overall Survival (OS)
OS is defined as the time from the start of study treatment to death due to any cause. OS data is censored on the last day they were known to be alive in the absence of confirmation of death.
Measured: A survival survey was conducted at least every 6 months after the completion of study treatment or withdrawal from the study.
Trough Plasma Concentration (Ctrough) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)
SU012662 is a metabolite of sunitinib. Trough plasma concentration (Ctrough) means the concentration prior to study drug administration.
The Ctrough for total drug (sunitinib+SU012662) was calculated as the mean of the Ctrough of total drug from individual participant.
Measured: Days 14 and 15 of Cycle 1
Tmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)
SU012662 is a metabolite of sunitinib. Tmax means a time to first occurrence of maximum observed plasma concentration (Cmax).
The Tmax for total drug (sunitinib+SU012662) was calculated as the median of the Tmax of total drug from individual participant.
Measured: Days 14 and 15 of Cycle 1
Cmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)
SU012662 is a metabolite of sunitinib. Cmax means a maximum observed plasma concentration.
The Cmax for total drug (sunitinib+SU012662) was calculated as the mean of the Cmax of total drug from individual participant.
Measured: Days 14 and 15 of Cycle 1
AUC(0-24) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)
SU012662 is a metabolite of sunitinib. AUC(0-24) means an area under the plasma concentration time curve from time zero to 24 hours post-dose.
The AUC(0-24) for total drug (sunitinib+SU012662) was calculated as the mean of the AUC(0-24) of total drug from individual participant.
Measured: Days 14 and 15 of Cycle 1
Tmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)
Tmax means a time to first occurrence of maximum observed plasma concentration (Cmax).
5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil
Measured: Day 14 of Cycle 1
Cmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)
Cmax means a maximum observed plasma concentration. 5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil
Measured: Day 14 of Cycle 1
AUC(0-inf) for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)
AUC(0-inf) means an area under the plasma concentration time curve from time zero to Infinity.
5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil
Measured: Day 14 of Cycle 1
t1/2 for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)
t1/2 means a terminal phase half-life. 5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil
Measured: Day 14 of Cycle 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2009
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced/Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662025
- Sponsor's protocol ID
- A6181163
- Status last verified
- May 2013
- First submitted
- 17 Apr 2008
- Last updated
- 27 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Of Sunitinib Malate In Combination With Capecitabine In Patients With Advanced Or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00662025
- Acronym / sponsor ID
- A6181163
- Conditions
- Advanced/Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 21 Apr 2008 (estimated)
- Results
- Posted 13 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate efficacy, safety and pharmacokinetics of sunitinib plus Capecitabine in Japanese patients with advanced/metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Capecitabine, Drug: Sunitinib |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically- or cytologically-proven diagnosis of breast adenocarcinoma that is not amenable to surgery, radiation, or combined modality therapy with curative intent
- Measurable disease as per RECIST. Measurable lesions that have been previously irradiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy.
- Prior treatment with an anthracycline and a taxane in the neoadjuvant, adjuvant or metastatic disease settings.
Key exclusion criteria (3 listed)
- Histology of inflammatory carcinoma with no other measurable disease. Patients with histology of inflammatory carcinoma are allowed on study if they have measurable disease.
- Brain metastases, spinal cord compression, or carcinomatous meningitis, or leptomeningeal disease.
- Prior treatment with 5-fluorouracil (5-FU) and 5-FU derivatives such as Furtulon (5'-DFUR), Futraful/ Sunfural (tegafur), UFT/UFT-E (tegafur/uracil), TS-1 (tegafur/gimeracil/oteracil) or Mifurol (carmofur) in metastatic disease setting
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 |
|---|---|---|
| CapecitabineCapecitabine 1000 mg/m2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles | Drug | 1 |
| SunitinibSunitinib 37.5 mg daily, continuous dosing | Drug | 1 |
Primary outcome
Number of Participants With Objective Response Based on Data Review Committee's Assessment
Time frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8.
Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST). CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the longest dimensions (LDs) of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.
16 secondary outcomes
Number of Participants With Objective Response Based on Investigator's Assessment
Time frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study.
Number of Participants With Clinical Benefit Response (CBR) Based on Data Review Committee's Assessment
Time frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8.
Number of Subjects With CBR Based on Investigator's Assessment
Time frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study.
Progression-Free Survival (PFS)
Time frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.
Time to Tumor Progression (TTP)
Time frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.
Duration of Objective Tumor Response (DR)
Time frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.
Time to Objective Tumor Response (TTR)
Time frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.
Overall Survival (OS)
Time frame: A survival survey was conducted at least every 6 months after the completion of study treatment or withdrawal from the study.
Trough Plasma Concentration (Ctrough) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)
Time frame: Days 14 and 15 of Cycle 1
Tmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)
Time frame: Days 14 and 15 of Cycle 1
Cmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)
Time frame: Days 14 and 15 of Cycle 1
AUC(0-24) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)
Time frame: Days 14 and 15 of Cycle 1
Tmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)
Time frame: Day 14 of Cycle 1
Cmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)
Time frame: Day 14 of Cycle 1
AUC(0-inf) for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)
Time frame: Day 14 of Cycle 1
t1/2 for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)
Time frame: Day 14 of Cycle 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine and Sunitinib in people with Advanced/Metastatic Breast Cancer, run by Pfizer at 17 sites in Japan.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Objective Response Based on Data Review Committee's Assessment (time frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8.). 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 27 May 2013.