Metastatic Breast CancerPhase 2NCT00434356
A Study of Sunitinib in Combination With Bevacizumab and Paclitaxel in Previously Untreated Patients With Metastatic Breast Cancer (SABRE-B)
A Phase 2 study testing bevacizumab, sunitinib and paclitaxel in people with Metastatic Breast Cancer, run by Genentech, Inc..
Trial summary
This is a multicenter, Phase II, randomized, controlled, open label trial designed to provide a preliminary assessment of the safety and efficacy of sunitinib when combined with bevacizumab and paclitaxel in patients who have not previously received chemotherapy for locally recurrent or metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- bevacizumab, sunitinib and paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to May 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form
- Histologically or cytologically confirmed adenocarcinoma of the breast with measurable or non-measurable locally recurrent or metastatic disease
- Age ≥ 18 years
- Adequate left ventricular function at study entry, defined as an Left Ventricular Ejection Fraction (LVEF) > 50% by either Multi Gated Acquisition(MUGA) scan or Electrocardiogram (ECHO)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Ability and willingness to comply with study and follow-up procedures
Who cannot join
- Unknown HER2 status or known HER2-positive status
- Prior chemotherapy for locally recurrent or metastatic disease
- Prior hormonal therapy within 2 weeks prior to Day 1
- Prior adjuvant or neoadjuvant taxane chemotherapy within 12 months prior to Day 1
- Prior adjuvant or neoadjuvant non-taxane chemotherapy within 6 months prior to Day 1
- For patients who have received recent radiotherapy, ongoing Grade ≥ 3 acute toxicity
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- Patients with brain metastasis on full dose anticoagulation therapy
- Life expectancy of < 12 weeks
- Current, recent (within 4 weeks of Day 1), or planned participation in an experimental drug study
- Inadequate organ function within 28 days prior to Day 1
- Untreated abnormal thyroid function tests
- Uncontrolled serious medical or psychiatric illness
- Active infection requiring IV antibiotics at enrollment or randomization
- History of other malignancies within 5 years prior to Day 1 except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix
- Inadequately controlled hypertension
- Prior history of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association (NYHA) Class II or greater CHF
- History of myocardial infarction or unstable angina within 12 months prior to Day 1
- History of stroke or transient ischemic attack within 12 months prior to Day 1
- Known central nervous system (CNS) disease except for treated brain metastasis
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent peripheral arterial thrombosis within 6 months prior to Day 1
- History of hemoptysis within 1 month prior to Day 1
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1
- History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1
- Serious, non-healing wound, active ulcer, or untreated bone fracture
- Proteinuria at screening, as demonstrated by a urine protein/creatinine ratio of ≥ 1.0 at screening
- Known hypersensitivity to any component of bevacizumab or sunitinib
- Pregnancy (positive pregnancy test) or lactation
About this study
Official title: A Multicenter, Phase II, Randomized, Controlled Trial Evaluating the Efficacy and Safety of Sunitinib in Combination With Bevacizumab and Paclitaxel in Previously Untreated Patients With Metastatic Breast Cancer
This is a multicenter, Phase II, randomized, controlled, open label trial designed to provide a preliminary assessment of the safety and efficacy of sunitinib when combined with bevacizumab and paclitaxel in patients who have not previously received chemotherapy for locally recurrent or metastatic breast cancer.
- Conditions
- Metastatic Breast Cancer
- Being tested
- bevacizumab, sunitinib, paclitaxel
- Keywords
- Avastin, MBC, Breast Cancer, Sutent
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabDrug
Intravenous repeating dose
sunitinibDrug
Oral repeating dose
paclitaxelDrug
Intravenous repeating dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: bevacizumab; Drug: sunitinib; Drug: paclitaxel |
| 2 | Placebo comparator | Not described Receives: Drug: bevacizumab; Drug: paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Response
The best overall response is the best response, per the Response Evaluation Criteria In Solid Tumors (RECIST) criteria, recorded from randomization until disease progression/recurrence (includes both confirmed and unconfirmed responses). Although the original primary outcome was progression-free survival, there was insufficient data available to report on that outcome.
Measured: From randomization until disease progression/recurrence (by patient)
Secondary outcomes (5)
Serious Adverse Events (SAEs)
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. An SAE is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator
Measured: 30 days following the last administration of study treatment
Grade ≥ 3 Adverse Events (AEs)
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. Grading: 1=Mild AE; 2=Moderate AE; 3=Severe AE; 4=Life-threatening or disabling AE; 5=Death related to AE
Measured: 30 days following the last administration of study treatment
Adverse Events Leading to Death
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
Measured: 30 days following the last administration of study treatment
Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
Measured: 30 days following the last administration of study treatment
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
Measured: 30 days following the last administration of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2007 (estimated)
- Study startMar 2007
- Primary completionMay 2008
Why it stopped: Based on data collected, the combination appeared to be poorly tolearated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jai Balkissoon, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00434356
- Sponsor's protocol ID
- AVF4057g
- Status last verified
- Nov 2009
- First submitted
- 9 Feb 2007
- Last updated
- 3 Dec 2009
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase II, Randomized, Controlled Trial Evaluating the Efficacy and Safety of Sunitinib in Combination With Bevacizumab and Paclitaxel in Previously Untreated Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00434356
- Acronym / sponsor ID
- AVF4057g
- Conditions
- Metastatic Breast Cancer
- Keywords
- Avastin, MBC, Breast Cancer, Sutent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on data collected, the combination appeared to be poorly tolearated.
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- May 2008 (actual)
- First posted
- 13 Feb 2007 (estimated)
- Results
- Posted 3 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, Phase II, randomized, controlled, open label trial designed to provide a preliminary assessment of the safety and efficacy of sunitinib when combined with bevacizumab and paclitaxel in patients who have not previously received chemotherapy for locally recurrent or metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: bevacizumab, Drug: sunitinib, Drug: paclitaxel |
| 2 | Placebo comparator | Drug: bevacizumab, Drug: paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed Informed Consent Form
- Histologically or cytologically confirmed adenocarcinoma of the breast with measurable or non-measurable locally recurrent or metastatic disease
- Age ≥ 18 years
- Adequate left ventricular function at study entry, defined as an Left Ventricular Ejection Fraction (LVEF) > 50% by either Multi Gated Acquisition(MUGA) scan or Electrocardiogram (ECHO)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (30 listed)
- Unknown HER2 status or known HER2-positive status
- Prior chemotherapy for locally recurrent or metastatic disease
- Prior hormonal therapy within 2 weeks prior to Day 1
- Prior adjuvant or neoadjuvant taxane chemotherapy within 12 months prior to Day 1
- Prior adjuvant or neoadjuvant non-taxane chemotherapy within 6 months prior to Day 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bevacizumabIntravenous repeating dose | Drug | 1, 2 |
| sunitinibOral repeating dose | Drug | 1 |
| paclitaxelIntravenous repeating dose | Drug | 1, 2 |
Primary outcome
Best Response
Time frame: From randomization until disease progression/recurrence (by patient)
The best overall response is the best response, per the Response Evaluation Criteria In Solid Tumors (RECIST) criteria, recorded from randomization until disease progression/recurrence (includes both confirmed and unconfirmed responses). Although the original primary outcome was progression-free survival, there was insufficient data available to report on that outcome.
5 secondary outcomes
Serious Adverse Events (SAEs)
Time frame: 30 days following the last administration of study treatment
Grade ≥ 3 Adverse Events (AEs)
Time frame: 30 days following the last administration of study treatment
Adverse Events Leading to Death
Time frame: 30 days following the last administration of study treatment
Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Time frame: 30 days following the last administration of study treatment
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Time frame: 30 days following the last administration of study treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jai Balkissoon, M.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bevacizumab, sunitinib and paclitaxel in people with Metastatic Breast Cancer, run by Genentech, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Response (time frame: From randomization until disease progression/recurrence (by patient)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2009.