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

Status

Completed

Conditions

Intervention / Treatment

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

    • California
      • Bakersfield, California, United States, 93309
        • Pfizer Investigational Site
      • Burbank, California, United States, 91505-4866
        • Pfizer Investigational Site
      • Fountain Valley, California, United States, 92708
        • Pfizer Investigational Site
      • Hawthorne, California, United States, 90250
        • Pfizer Investigational Site
      • Long Beach, California, United States, 90806
        • Pfizer Investigational Site
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • Pfizer Investigational Site
    • Illinois
      • Zion, Illinois, United States, 60099
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Pfizer Investigational Site
    • Michigan
      • Kalamazoo, Michigan, United States, 49007
        • Pfizer Investigational Site
    • Minnesota
      • Maple Grove, Minnesota, United States, 55369
        • Pfizer Investigational Site
      • Minneapolis, Minnesota, United States, 55454
        • Pfizer Investigational Site
      • Minneapolis, Minnesota, United States, 55455
        • Pfizer Investigational Site
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Pfizer Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28806
        • Pfizer Investigational Site
      • Chapel Hill, North Carolina, United States, 27599
        • Pfizer Investigational Site
      • Kernersville, North Carolina, United States, 27284
        • Pfizer Investigational Site
      • Lexington, North Carolina, United States, 27292
        • Pfizer Investigational Site
      • North Wilkesboro, North Carolina, United States, 28659
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Pfizer Investigational Site
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Pfizer Investigational Site
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Pfizer Investigational Site
      • Gallatin, Tennessee, United States, 37066
        • Pfizer Investigational Site
      • Hermitage, Tennessee, United States, 37076
        • Pfizer Investigational Site
      • Lebanon, Tennessee, United States, 37087
        • Pfizer Investigational Site
      • Murfreesboro, Tennessee, United States, 37130
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37203
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37205
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37207
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37211
        • Pfizer Investigational Site
      • Smyrna, Tennessee, United States, 37167
        • Pfizer Investigational Site
    • Washington
      • Everett, Washington, United States, 98201
        • Pfizer Investigational Site

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
sunitinib (Sutent), 37.5 mg, daily dosing
Other Names:
  • Sutent, sunitinib

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
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.
Baseline, Week 9, and every 8 weeks up to Month 34

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
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.
Baseline, Week 9, and every 8 weeks up to Month 34
Number of Participants With Objective Response of Superficial Lesions
Time Frame: Baseline, every 4 weeks up to Month 34
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.
Baseline, every 4 weeks up to Month 34
Progression-Free Survival (PFS)
Time Frame: Baseline up to Month 34
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.
Baseline up to Month 34
Duration of Response (DR)
Time Frame: Baseline up to Month 34 or early termination
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.
Baseline up to Month 34 or early termination
Overall Survival (OS)
Time Frame: Baseline until death (up to Month 34)
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.
Baseline until death (up to Month 34)
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
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.
Baseline, Week 9, and every 8 weeks up to Month 34
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
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.
Baseline, every 4 weeks up to Month 31 or early termination
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
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
Change From Baseline in EORTC-QLQ-BR23 Score: Future Perspective
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
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
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
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.
Baseline, every 4 weeks up to Month 31 or early termination
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
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
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
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
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: 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
Probability of survival 1 year after the first dose of study treatment.
Baseline up to 1 year

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

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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