A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer
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| ClinicalTrials.gov Identifier: NCT00373256 |
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Recruitment Status :
Completed
First Posted : September 8, 2006
Results First Posted : October 8, 2010
Last Update Posted : September 10, 2012
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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Brief Summary:
To compare treatment with SU011248 plus paclitaxel versus bevacizumab plus paclitaxel to determine which treatment works better against breast cancer
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Neoplasms | Drug: Sunitinib Drug: paclitaxel Drug: bevacizumab | Phase 3 |
On May 27, 2009, the independent Data Monitoring Committee (DMC) reviewed the progress of Study A6181094. The DMC determined Study A6181094 had met pre-specified futility criteria and was unlikely to meet its primary endpoint to demonstrate a statistically significant improvement in progression-free survival (PFS) in patients treated with sunitinib plus paclitaxel versus bevacizumab plus paclitaxel. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings. Enrollment in this study has been stopped.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 488 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3 Study Of SU011248 In Combination With Paclitaxel Versus Bevacizumab With Paclitaxel In The First-Line Advanced Disease Setting In Patients Having Breast Cancer |
| Study Start Date : | November 2006 |
| Actual Primary Completion Date : | June 2009 |
| Actual Study Completion Date : | August 2011 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
MedlinePlus related topics:
Breast Cancer
| Arm | Intervention/treatment |
|---|---|
| Experimental: A |
Drug: Sunitinib
Sunitinib 25 mg daily by oral capsules with titration up to 37.5 mg,
Other Name: SU011248, Sutent Drug: paclitaxel Paclitaxel 90 mg/m2 IV, 3 weekly doses every 28 days until progression or unacceptable toxicity. |
| Active Comparator: B |
Drug: bevacizumab
Bevacizumab 10 mg/kg IV every 2 weeks.
Other Name: Avastin Drug: paclitaxel Paclitaxel 90 mg/m2 IV, 3 weekly doses every 28 days until progression or unacceptable toxicity. |
Primary Outcome Measures :
- Progression-Free Survival (PFS) [ Time Frame: From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death ]Time from date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS = (first event date minus randomization date +1) divided by 30.4
Secondary Outcome Measures :
- Number of Participants With Objective Response [ Time Frame: From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months ]Objective response = participants with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions. A PR was defined as a > = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
- Duration of Response (DR) [ Time Frame: From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death due to any cause ]DR=time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to first documentation of objective disease progression or death due to any cause, whichever was first. DR was calculated as [the date response ended (ie, date of progressive disease or death) minus first CR or PR date that was subsequently confirmed +1)] divided by 30.4.
- Overall Survival (OS) [ Time Frame: From date of randomization up to 5 years. Survival follow-up changed to 28-days after treatment discontinuation when study was discontinued. ]OS was defined as the time from date of randomization to death due to any cause. OS (in months) was calculated as (date of death minus randomization date +1) divided by 30.4.
- Percentage of Participants Surviving at 1 and 2 Years [ Time Frame: Year 1, Year 2 ]Percentage of those surviving at the end of one year or end of 2 years from the first dose of study treatment.
- European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) [ Time Frame: Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months ]EORTC QLQ-C30: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
- EORTC QLQ Breast Cancer Module (BR23) [ Time Frame: Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months ]BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.
- Euro Quality of Life-5 Dimension (EQ-5D) [ Time Frame: Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months ]EQ-5D: health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities). Three-level scale (1=no problem, 2=some problem, and 3=extreme problem). A single score between 1 and 3 is generated for each domain. For each subject, the outcome rating on the 5 domains could be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the subject.
- EQ - Visual Analog Scale (EQ-VAS) [ Time Frame: Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months ]EQ-VAS score on the self-rated "thermometer," indicating the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state.
- Biomarkers [ Time Frame: Day 1 of Cycles 1 through 3 and 5, Day 8 of Cycle 1, and Day 15 of Cycle 1 ]Concentrations of plasma proteins (eg, soluble Vascular Endothelial Growth Factor Receptor 2 [VEGFR2] and VEGFR3, VEGF-A, placental growth factor [PlGF], soluble KIT, and possibly soluble PDGFRβ and PDGF) that may be associated with angiogenesis and tumor proliferation.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of advanced breast cancer.
- Measurable disease as per RECIST (Response Evaluation Criterion) in Solid Tumors or bone-only disease.
- ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.
Exclusion Criteria:
- No prior treatment with cytotoxics in the advanced disease setting.
- HER2/neu positive disease unless trastuzumab was previously received or is contraindicated.
- Treatment with a taxane in the adjuvant setting unless disease free interval >12 months after end of treatment.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373256
Locations
Show 250 study locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00373256 |
| Other Study ID Numbers: |
A6181094 |
| First Posted: | September 8, 2006 Key Record Dates |
| Results First Posted: | October 8, 2010 |
| Last Update Posted: | September 10, 2012 |
| Last Verified: | September 2012 |
Keywords provided by Pfizer:
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Breast cancer advanced sunitinib |
bevacizumab paclitaxel Phase 3 |
Additional relevant MeSH terms:
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Albumin-Bound Paclitaxel Bevacizumab Sunitinib Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators |
Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors |