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Efficacy And Safety Of Sunitinib In Women With Advanced Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00471276
First received: May 7, 2007
Last updated: July 21, 2011
Last verified: July 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Breast Neoplasms
 Drug: sunitinib
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of Sunitinib Malate Single Agent For The Treatment Of Women With Advanced Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Objective Response [ Time Frame: Baseline, Week 9, and every 8 weeks up to Month 34 ] [ Designated as safety issue: No ]
    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:
  • Number of Participants With Clinical Benefit [ Time Frame: Baseline, Week 9, and every 8 weeks up to Month 34 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, every 4 weeks up to Month 34 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline up to Month 34 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline up to Month 34 or early termination ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline until death (up to Month 34) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 9, and every 8 weeks up to Month 34 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, every 4 weeks up to Month 31 or early termination ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, every 4 weeks up to Month 31 or early termination ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, every 4 weeks up to Month 31 or early termination ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, every 4 weeks up to Month 31 or early termination ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, every 4 weeks up to Month 31 or early termination ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, every 4 weeks up to Month 31 or early termination ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, every 4 weeks up to Month 31 or early termination ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, every 4 weeks up to Month 31 or early termination ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, every 4 weeks up to Month 31 or early termination ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination ] [ Designated as safety issue: No ]
    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.


Enrollment: 83
Study Start Date: August 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: sunitinib
sunitinib (Sutent), 37.5 mg, daily dosing
Other Name: Sutent, sunitinib

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00471276

  Show 31 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00471276     History of Changes
Other Study ID Numbers: A6181068
Study First Received: May 7, 2007
Results First Received: June 23, 2011
Last Updated: July 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Metastatic Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Sunitinib
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013