- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00471276
Efficacy And Safety Of Sunitinib In Women With Advanced Breast Cancer
July 21, 2011 updated by: Pfizer
A Phase II Study Of Sunitinib Malate Single Agent For The Treatment Of Women With Advanced Breast Cancer
Patients with advanced breast cancer to receive sunitinib (Sutent) once daily until disease progression.
Study Overview
Study Type
Interventional
Enrollment (Actual)
83
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Bakersfield, California, United States, 93309
- Pfizer Investigational Site
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Burbank, California, United States, 91505-4866
- Pfizer Investigational Site
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Fountain Valley, California, United States, 92708
- Pfizer Investigational Site
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Hawthorne, California, United States, 90250
- Pfizer Investigational Site
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Long Beach, California, United States, 90806
- Pfizer Investigational Site
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Florida
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Boynton Beach, Florida, United States, 33435
- Pfizer Investigational Site
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Illinois
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Zion, Illinois, United States, 60099
- Pfizer Investigational Site
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Kentucky
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Louisville, Kentucky, United States, 40207
- Pfizer Investigational Site
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Michigan
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Kalamazoo, Michigan, United States, 49007
- Pfizer Investigational Site
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Minnesota
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Maple Grove, Minnesota, United States, 55369
- Pfizer Investigational Site
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Minneapolis, Minnesota, United States, 55454
- Pfizer Investigational Site
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Minneapolis, Minnesota, United States, 55455
- Pfizer Investigational Site
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Missouri
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Columbia, Missouri, United States, 65203
- Pfizer Investigational Site
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North Carolina
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Asheville, North Carolina, United States, 28806
- Pfizer Investigational Site
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Chapel Hill, North Carolina, United States, 27599
- Pfizer Investigational Site
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Kernersville, North Carolina, United States, 27284
- Pfizer Investigational Site
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Lexington, North Carolina, United States, 27292
- Pfizer Investigational Site
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North Wilkesboro, North Carolina, United States, 28659
- Pfizer Investigational Site
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Winston-Salem, North Carolina, United States, 27103
- Pfizer Investigational Site
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North Dakota
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Bismarck, North Dakota, United States, 58501
- Pfizer Investigational Site
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Tennessee
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Franklin, Tennessee, United States, 37067
- Pfizer Investigational Site
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Gallatin, Tennessee, United States, 37066
- Pfizer Investigational Site
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Hermitage, Tennessee, United States, 37076
- Pfizer Investigational Site
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Lebanon, Tennessee, United States, 37087
- Pfizer Investigational Site
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Murfreesboro, Tennessee, United States, 37130
- Pfizer Investigational Site
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Nashville, Tennessee, United States, 37203
- Pfizer Investigational Site
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Nashville, Tennessee, United States, 37205
- Pfizer Investigational Site
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Nashville, Tennessee, United States, 37207
- Pfizer Investigational Site
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Nashville, Tennessee, United States, 37211
- Pfizer Investigational Site
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Smyrna, Tennessee, United States, 37167
- Pfizer Investigational Site
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Washington
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Everett, Washington, United States, 98201
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Histologically or cytologically proven diagnosis of breast cancer
- Metastatic or locally recurrent disease that is, in the opinion of the investigator, not amenable to resection or radiation therapy
- Patients with at least one measurable lesion as per RECIST
Exclusion Criteria:
- Inflammatory breast cancer
- Prior treatment with VEGF inhibitors (unless in adjuvant setting at least 12 months ago)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
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sunitinib (Sutent), 37.5 mg, daily dosing
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Objective Response
Time Frame: Baseline, Week 9, and every 8 weeks up to Month 34
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Number 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 disappearance of all target lesions.
PR defined as a greater than or equal to 30 percent (≥30%) decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
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Baseline, Week 9, and every 8 weeks up to Month 34
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Clinical Benefit
Time Frame: Baseline, Week 9, and every 8 weeks up to Month 34
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The sum of participants with confirmed CR, PR, and stable disease (SD) greater than (>) 6 months according to RECIST.
SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference smallest sum of longest dimensions since treatment started.
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Baseline, Week 9, and every 8 weeks up to Month 34
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Number of Participants With Objective Response of Superficial Lesions
Time Frame: Baseline, every 4 weeks up to Month 34
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Number of participants with objective response based assessment of confirmed CR or PR of superficial lesions according to RECIST.
Superficial lesions included skin lesions, chest wall lesions, and breast lesions and lymph nodes if followed up by physical examination.
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Baseline, every 4 weeks up to Month 34
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Progression-Free Survival (PFS)
Time Frame: Baseline up to Month 34
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Time from date of randomization to date of 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.
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Baseline up to Month 34
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Duration of Response (DR)
Time Frame: Baseline up to Month 34 or early termination
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Time from first objective documentation of complete or partial response that was subsequently confirmed to first documentation of disease progression or death due to any cause, whichever occurred first.
DR calculated as (Weeks)=(end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.
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Baseline up to Month 34 or early termination
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Overall Survival (OS)
Time Frame: Baseline until death (up to Month 34)
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Time from randomization to date of death due to any cause.
OS (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.
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Baseline until death (up to Month 34)
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Number of Participants With Objective Response for Subgroup of Participants Whom Sunitinib Was at Least a Third Line Therapy
Time Frame: Baseline, Week 9, and every 8 weeks up to Month 34
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Number of participants with objective response based assessment of confirmed CR or PR according to RECIST.
CR defined as disappearance of all target lesions.
PR defined as ≥30% decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
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Baseline, Week 9, and every 8 weeks up to Month 34
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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 4 weeks up to Month 31 or early termination
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EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties).
Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent').
Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.
Change from baseline=Cycle/Day score minus baseline score.
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Baseline, every 4 weeks up to Month 31 or early termination
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Change From Baseline in EORTC-QLQ Companion Breast Cancer Module (EORTC-QLQ-BR23) Score: Body Image
Time Frame: Baseline, every 4 weeks up to Month 31 or early termination
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EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss).
Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much').
Scores averaged and transformed to 0-100 scale.
High score for functional scale=high/healthy level of functioning.
High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.
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Baseline, every 4 weeks up to Month 31 or early termination
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Change From Baseline in EORTC-QLQ-BR23 Score: Future Perspective
Time Frame: Baseline, every 4 weeks up to Month 31 or early termination
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EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss).
Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much').
Scores averaged and transformed to 0-100 scale.
High score for functional scale=high/healthy level of functioning.
High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.
|
Baseline, every 4 weeks up to Month 31 or early termination
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Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Enjoyment
Time Frame: Baseline, every 4 weeks up to Month 31 or early termination
|
EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss).
Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much').
Scores averaged and transformed to 0-100 scale.
High score for functional scale=high/healthy level of functioning.
High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.
|
Baseline, every 4 weeks up to Month 31 or early termination
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Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Functioning
Time Frame: Baseline, every 4 weeks up to Month 31 or early termination
|
EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss).
Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much').
Scores averaged and transformed to 0-100 scale.
High score for functional scale=high/healthy level of functioning.
High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.
|
Baseline, every 4 weeks up to Month 31 or early termination
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Change From Baseline in EORTC-QLQ-BR23 Score: Arm Symptoms
Time Frame: Baseline, every 4 weeks up to Month 31 or early termination
|
EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss).
Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much').
Scores averaged and transformed to 0-100 scale.
High score for functional scale=high/healthy level of functioning.
High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.
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Baseline, every 4 weeks up to Month 31 or early termination
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Change From Baseline in EORTC-QLQ-BR23 Score: Breast Symptoms
Time Frame: Baseline, every 4 weeks up to Month 31 or early termination
|
EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss).
Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much').
Scores averaged and transformed to 0-100 scale.
High score for functional scale=high/healthy level of functioning.
High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.
|
Baseline, every 4 weeks up to Month 31 or early termination
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Change From Baseline in EORTC-QLQ-BR23 Score: Systemic Therapy Side Effects
Time Frame: Baseline, every 4 weeks up to Month 31 or early termination
|
EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss).
Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much').
Scores averaged and transformed to 0-100 scale.
High score for functional scale=high/healthy level of functioning.
High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.
|
Baseline, every 4 weeks up to Month 31 or early termination
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Change From Baseline in EORTC-QLQ-BR23 Score: Upset by Hair Loss
Time Frame: Baseline, every 4 weeks up to Month 31 or early termination
|
EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss).
Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much').
Scores averaged and transformed to 0-100 scale.
High score for functional scale=high/healthy level of functioning.
High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.
|
Baseline, every 4 weeks up to Month 31 or early termination
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Change From Baseline in Cancer Therapy Satisfaction Questionnaire (CTSQ) Score: Expectation of Therapy
Time Frame: Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination
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CTSQ: included 3 multi-item subscales (Expectation of Therapy [ET], Satisfaction with Therapy [SWT], and Feelings about Side Effects [FSE]).
Questions used 5-point scale from 1 'Never' to 5 'Always'.
Scores averaged and transformed to 0-100 scale, with higher scores associated with better outcomes.
Change from baseline=score for Cycle/Day minus baseline score.
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Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination
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Change From Baseline in CTSQ Score: Feelings About Side Effects
Time Frame: Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination
|
CTSQ: included 3 multi-item subscales (Expectation of Therapy [ET], Satisfaction with Therapy [SWT], and Feelings about Side Effects [FSE]).
Questions used 5-point scale from 1 'Never' to 5 'Always'.
Scores averaged and transformed to 0-100 scale, with higher scores associated with better outcomes.
Change from baseline=score for Cycle/Day minus baseline score.
|
Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination
|
Change From Baseline in CTSQ Score: Satisfaction With Therapy
Time Frame: Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination
|
CTSQ: included 3 multi-item subscales (Expectation of Therapy [ET], Satisfaction with Therapy [SWT], and Feelings about Side Effects [FSE]).
Questions used 5-point scale from 1 'Never' to 5 'Always'.
Scores averaged and transformed to 0-100 scale, with higher scores associated with better outcomes.
Change from baseline=score for Cycle/Day minus baseline score.
|
Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
1-Year Survival Probability
Time Frame: Baseline up to 1 year
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Probability of survival 1 year after the first dose of study treatment.
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Baseline up to 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
May 7, 2007
First Submitted That Met QC Criteria
May 7, 2007
First Posted (Estimate)
May 9, 2007
Study Record Updates
Last Update Posted (Estimate)
July 25, 2011
Last Update Submitted That Met QC Criteria
July 21, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Sunitinib
Other Study ID Numbers
- A6181068
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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