Efficacy And Safety Of Sunitinib In Women With Advanced Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

A Phase II Study Of Sunitinib Malate Single Agent For The Treatment Of Women With Advanced Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00471276
• Other study ID #: A6181068
• Status: Completed
• Phase: Phase 2
• First received: May 7, 2007
• Last updated: July 21, 2011
• Start date: August 2007
• Est. completion date: June 2010

Study information

• Verified date: July 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Patients with advanced breast cancer to receive sunitinib (Sutent) once daily until disease progression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• sunitinib
sunitinib (Sutent), 37.5 mg, daily dosing

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Asheville	North Carolina
United States	Pfizer Investigational Site	Bakersfield	California
United States	Pfizer Investigational Site	Bismarck	North Dakota
United States	Pfizer Investigational Site	Boynton Beach	Florida
United States	Pfizer Investigational Site	Burbank	California
United States	Pfizer Investigational Site	Chapel Hill	North Carolina
United States	Pfizer Investigational Site	Columbia	Missouri
United States	Pfizer Investigational Site	Everett	Washington
United States	Pfizer Investigational Site	Fountain Valley	California
United States	Pfizer Investigational Site	Franklin	Tennessee
United States	Pfizer Investigational Site	Gallatin	Tennessee
United States	Pfizer Investigational Site	Hawthorne	California
United States	Pfizer Investigational Site	Hermitage	Tennessee
United States	Pfizer Investigational Site	Kalamazoo	Michigan
United States	Pfizer Investigational Site	Kernersville	North Carolina
United States	Pfizer Investigational Site	Lebanon	Tennessee
United States	Pfizer Investigational Site	Lexington	North Carolina
United States	Pfizer Investigational Site	Long Beach	California
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Maple Grove	Minnesota
United States	Pfizer Investigational Site	Minneapolis	Minnesota
United States	Pfizer Investigational Site	Minneapolis	Minnesota
United States	Pfizer Investigational Site	Murfreesboro	Tennessee
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	North Wilkesboro	North Carolina
United States	Pfizer Investigational Site	Smyrna	Tennessee
United States	Pfizer Investigational Site	Winston-Salem	North Carolina
United States	Pfizer Investigational Site	Zion	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Objective Response	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	No
Secondary	Number of Participants With Clinical Benefit	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	No
Secondary	Number of Participants With Objective Response of Superficial Lesions	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	No
Secondary	Progression-Free Survival (PFS)	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	No
Secondary	Duration of Response (DR)	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	No
Secondary	Overall Survival (OS)	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)	No
Secondary	Number of Participants With Objective Response for Subgroup of Participants Whom Sunitinib Was at Least a Third Line Therapy	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	No
Secondary	Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score	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	No
Secondary	Change From Baseline in EORTC-QLQ Companion Breast Cancer Module (EORTC-QLQ-BR23) Score: Body Image	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	No
Secondary	Change From Baseline in EORTC-QLQ-BR23 Score: Future Perspective	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	No
Secondary	Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Enjoyment	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	No
Secondary	Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Functioning	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	No
Secondary	Change From Baseline in EORTC-QLQ-BR23 Score: Arm Symptoms	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	No
Secondary	Change From Baseline in EORTC-QLQ-BR23 Score: Breast Symptoms	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	No
Secondary	Change From Baseline in EORTC-QLQ-BR23 Score: Systemic Therapy Side Effects	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	No
Secondary	Change From Baseline in EORTC-QLQ-BR23 Score: Upset by Hair Loss	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	No
Secondary	Change From Baseline in Cancer Therapy Satisfaction Questionnaire (CTSQ) Score: Expectation of Therapy	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	No
Secondary	Change From Baseline in CTSQ Score: Feelings About Side Effects	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	No
Secondary	Change From Baseline in CTSQ Score: Satisfaction With Therapy	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	No

External Links

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