A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine

Phase 3TerminatedNCT00373113

Pfizer482 enrolled

Overview

To compare efficacy and safety of Sunitinib and 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

482

Conditions

Breast Neoplasms

Interventions

CapecitabineDRUG

1250 mg/m\^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles

Sunitinib malateDRUG

37.5 mg daily, continuous dosing

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (123)

Outcomes

Primary Outcomes

Progression-Free Survival (PFS)

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.

Time frame: From time of randomization to every 6 weeks thereafter through 22 months or until death

Secondary Outcomes

Time to Tumor Progression (TTP)

Time from randomization to first documentation of objective tumor progression.

Time frame: From time of randomization to every 6 weeks thereafter through 22 months

Number of Participants With Overall Response (OR)

OR was defined as the number of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.0) for at least 4 weeks, confirmed by repeat tumor assessments. CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to (\>=) 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Time frame: From time of randomization to every 6 weeks thereafter through 22 months

Duration of Response (DR)

Time from the first documentation of OR (CR or PR) that was subsequently confirmed to the first documentation of tumor progression or death due to any cause. CR was defined as disappearance of all target lesions. PR was defined as a \>= 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.

Time frame: From time of randomization to every 6 weeks thereafter through 22 months or death

Time to Tumor Response (TTR)

Time from randomization to the first documentation of objective tumor response (CR or PR) that was subsequently confirmed. CR was defined as disappearance of all target lesions. PR was defined as a \>= 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Pfizer Investigational Site

Córdoba, Córdoba Province, Argentina

Pfizer Investigational Site

Bahía Blanca, Prov. de Buenos Aires, Argentina

Pfizer Investigational Site

Viedma, Río Negro Province, Argentina

Pfizer Investigational Site

Rosario, Santa Fe Province, Argentina

Pfizer Investigational Site

Buenos Aires, Argentina

Pfizer Investigational Site

Buenos Aires, Argentina

Pfizer Investigational Site

San Miguel de Tucumán, Argentina

Pfizer Investigational Site

Darlinghurst, New South Wales, Australia

Pfizer Investigational Site

Herston, Queensland, Australia

Pfizer Investigational Site

Adelaide, South Australia, Australia

...and 113 more locations