Study Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast Cancer

Phase 3

Completed

• Conditions: Breast Neoplasms
• Interventions: Drug: Taxotere; Drug: Sunitinib malate

• Registration Number: NCT00393939
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-10-30
• Study First Submitted QC: 2006-10-30
• Study First Posted: 2006-10-31
• Study Start: 2007-02
• Primary Completion: 2010-02
• Results First Submitted: 2011-01-31
• Results First Submitted QC: 2011-01-31
• Results First Posted: 2011-02-28
• Study Completion: 2011-07
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-13
• Last Update Posted: 2012-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 594

Inclusion Criteria

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

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Exclusion Criteria

• Patients for whom docetaxel is contraindicated
• Clinical presentation of inflammatory carcinoma with no other measurable disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Taxotere	-
A	Sunitinib malate	-

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	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

Name	Time	Method
Percentage of Participants With Objective Response	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.
Overall Survival (OS)	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.
Change From Baseline in EORTC-QLQ Breast Cancer Module (EORTC-QLQ-BR23) Score	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.
Change From Baseline European Quality of Life 5-dimensional Self-Report Questionnaire (EQ-5D) Score	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.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score	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.
Duration of Response (DR)	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Wolverhampton, United Kingdom