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Study Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast Cancer (SUN 1064)

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ClinicalTrials.gov Identifier: NCT00393939
Recruitment Status : Completed
First Posted : October 31, 2006
Results First Posted : February 28, 2011
Last Update Posted : July 19, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of sunitinib combined with docetaxel versus docetaxel, administered as first-line treatment, in patients with unresectable locally recurrent or metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Sunitinib malate Drug: Taxotere Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 594 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase 3 Study Of Docetaxel In Combination With Sunitinib Versus Docetaxel In The First-Line Treatment Of Advanced Breast Cancer Patients
Study Start Date : February 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: A Drug: Sunitinib malate
Sunitinib 37.5 mg daily by oral capsule in schedule 2/1 with Docetaxel 75 mg/m2 every 3 weeks or 37. 5 mg daily in continuous dosing (in absence of docetaxel)
Active Comparator: B Drug: Taxotere
Docetaxel 100 mg/m2 every 3 weeks in the comparator arm


Outcome Measures
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Primary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: Baseline up to Month 33 ]
    PFS defined as time from date of randomization to date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS calculated as (Months) = (first event date minus randomization date plus 1) divided by 30.4.


Secondary Outcome Measures :
  1. Percentage of Participants With Objective Response [ Time Frame: Baseline up to Month 33 ]
    Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all tumor lesions (target and non-target). PR defined as greater than or equal to 30 percent (≥30%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions with a non-progressive disease status of the non-target lesions.

  2. Duration of Response (DR) [ Time Frame: Baseline up to Month 33 ]
    DR defined as time from first objective documentation of complete or partial response that was subsequently confirmed to first documentation of disease progression or to death due to any cause, whichever occurred first. DR calculated (Months) = (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4.

  3. Overall Survival (OS) [ Time Frame: Baseline to date of death from any cause (up to Month 33) ]
    Time from randomization to date of death due to any cause. OS calculated as (Months) = (death date minus date of first dose of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored at last contact.

  4. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score [ Time Frame: Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33) ]
    EORTC QLQ-C30 measured 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnoea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. For functional domains and global health status, scores ranged from 0 to 100 where higher scores represented a better level of functioning. For symptoms scales, scores ranged from 0 to 100 where higher scores represented a greater degree of symptoms. Change from baseline = score for Cycle/Day minus baseline score.

  5. Change From Baseline in EORTC-QLQ Breast Cancer Module (EORTC-QLQ-BR23) Score [ Time Frame: Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33) ]
    EORTC-QLQ-BR23 measured multi-item functional scales for body image, sexual functioning, sexual enjoyment, and future perspective and measured single item symptoms scales which assessed systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss. For functional scales, scores ranged from 0 to 100 where higher scores represented a better level of functioning. For symptoms scales, scores ranged from 0 to 100 where higher scores represented a greater degree of symptoms. Change from baseline = score for Cycle/Day minus baseline score.

  6. Change From Baseline European Quality of Life 5-dimensional Self-Report Questionnaire (EQ-5D) Score [ Time Frame: Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33) ]
    EQ-5D: standardized, participant-administered 2 part measure of health outcome. Part 1: descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), used 3 levels (no, some, extreme problems) and a single index value characterized current health status using formula that weighted the dimensions. Part 2: overall rating of participant's current health used Visual Analog Scale with endpoints labeled 'best imaginable health state' and 'worst imaginable health state'. Change from baseline = score for Cycle/Day minus baseline score.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Breast cancer with evidence of unresectable locally recurrent, or metastatic disease
  • Her-2 negative tumors

Exclusion Criteria:

  • Patients for whom docetaxel is contraindicated
  • Clinical presentation of inflammatory carcinoma with no other measurable disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00393939


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00393939    
Other Study ID Numbers: A6181064
First Posted: October 31, 2006    Key Record Dates
Results First Posted: February 28, 2011
Last Update Posted: July 19, 2012
Last Verified: July 2012
Keywords provided by Pfizer:
advanced breast cancer
sunitinib
docetaxel
Phase 3
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Sunitinib
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
 Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors