Efficacy And Safety Of Sunitinib In Women With Advanced Breast Cancer
- Registration Number
- NCT00471276
- Lead Sponsor
- Pfizer
- Brief Summary
Patients with advanced breast cancer to receive sunitinib (Sutent) once daily until disease progression.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 83
- 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
- Inflammatory breast cancer
- Prior treatment with VEGF inhibitors (unless in adjuvant setting at least 12 months ago)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 sunitinib -
- Primary Outcome Measures
Name Time Method Number of Participants With Objective Response 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Clinical Benefit 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.
Number of Participants With Objective Response of Superficial Lesions 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.
Progression-Free Survival (PFS) 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.
Duration of Response (DR) 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.
Overall Survival (OS) 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.
Number of Participants With Objective Response for Subgroup of Participants Whom Sunitinib Was at Least a Third Line Therapy 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.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score 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.
Change From Baseline in EORTC-QLQ Companion Breast Cancer Module (EORTC-QLQ-BR23) Score: Body Image 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.
Change From Baseline in EORTC-QLQ-BR23 Score: Future Perspective 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.
Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Enjoyment 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.
Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Functioning 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.
Change From Baseline in EORTC-QLQ-BR23 Score: Arm Symptoms 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.
Change From Baseline in EORTC-QLQ-BR23 Score: Breast Symptoms 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.
Change From Baseline in EORTC-QLQ-BR23 Score: Systemic Therapy Side Effects 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.
Change From Baseline in EORTC-QLQ-BR23 Score: Upset by Hair Loss 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.
Change From Baseline in Cancer Therapy Satisfaction Questionnaire (CTSQ) Score: Expectation of Therapy 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.
Change From Baseline in CTSQ Score: Feelings About Side Effects 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.
Change From Baseline in CTSQ Score: Satisfaction With Therapy 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.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Everett, Washington, United States