Phase III Randomized, Multi Center Study Of Sunitinib Malate (SU 011248) Or Capecitabine In Subjects With Advanced Breast Cancer Who Failed Both A Taxane And An Anthracycline Chemotherapy Regimen Or Failed With A Taxane And For Whom Further Anthracycline Therapy Is Not Indicated
18 Years
N/A
Female
Breast Neoplasms
Trial Information
Phase III Randomized, Multi Center Study Of Sunitinib Malate (SU 011248) Or Capecitabine In Subjects With Advanced Breast Cancer Who Failed Both A Taxane And An Anthracycline Chemotherapy Regimen Or Failed With A Taxane And For Whom Further Anthracycline Therapy Is Not Indicated
Patient enrollment in this trial was discontinued based on statistical assessment for
futility. An independent Data Monitoring Committee found that even if the trial had been
allowed to continue, treatment with single agent sunitinib would be unable to demonstrate a
statistically significant improvement in the primary endpoint of progression-free survival
compared with single agent capecitabine in the study population. Pfizer notified clinical
trial investigators involved in the study and regulatory agencies of these findings on
25Mar2009. Patients receiving sunitinib will be allowed to receive capecitabine or enter an
extension trial if they are receiving clinical benefit from continued sunitinib therapy.
There were no safety concerns leading to the decision to terminate the study.
Inclusion Criteria:
- breast adenocarcinoma
- prior treatment with an anthracycline and a taxane either concurrently or
sequentially in the neoadjuvant, adjuvant and or/ advanced disease treatment
settings. No more than 1 chemotherapy regimen in the advanced setting
Exclusion Criteria:
- Prior treatment with regimens of chemotherapy in the advanced/metastatic disease
setting beyond those containing anthracyclines and taxanes or multiple
anthracyclines/ taxanes treatments.
- Any prior regimen with capecitabine
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-Free Survival (PFS)
Outcome Description:
Time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occured first.
Outcome Time Frame:
From time of randomization to every 6 weeks thereafter through 22 months or until death
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A6181107
NCT ID:
NCT00373113
Start Date:
November 2006
Completion Date:
June 2011
Related Keywords:
- Breast Neoplasms
- advanced breast cancer
- metastatic breast cancer
- treatment resistant
- treatment failure
- Breast Neoplasms
- Neoplasms
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