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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Breast Cancer

Thank you

Trial Information

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


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Best Response

Outcome Time Frame:

From randomization until disease progression/recurrence (by patient)

Safety Issue:

No

Principal Investigator

Jai Balkissoon, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

AVF4057g

NCT ID:

NCT00434356

Start Date:

March 2007

Completion Date:

Related Keywords:

  • Metastatic Breast Cancer
  • Avastin
  • MBC
  • Breast Cancer
  • Sutent
  • Breast Neoplasms

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