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A Phase II Open Label, Randomized, 3 Arm Trial of 2 Schedules of Ixabepilone Plus Bevacizumab and Paclitaxel Plus Bevacizumab as First Line Therapy for Locally Recurrent or Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Metastatic Breast Cancer

Thank you

Trial Information

A Phase II Open Label, Randomized, 3 Arm Trial of 2 Schedules of Ixabepilone Plus Bevacizumab and Paclitaxel Plus Bevacizumab as First Line Therapy for Locally Recurrent or Metastatic Breast Cancer

Inclusion Criteria

Inclusion criteria:

- Locally recurrent or metastatic breast cancer, previously untreated with chemotherapy
for advanced disease.

- At least 1 target lesion per RECIST criteria. Locally recurrent disease must not be
amenable to resection with curative intent.

- No previous cytotoxic chemotherapy for locally recurrent/metastatic disease.

- Relapse 12 months or more after completing prior adjuvant or neoadjuvant taxane

- No previous breast cancer known to overexpress or amplify the human epidermal growth
factor receptor 2 gene.

- Prior hormonal therapy in adjuvant, recurrent, or metastatic setting allowed but must
have been discontinued at least 2 weeks before randomization.

- Karnofsky performance status of 80 to 100 or Eastern Cooperative Oncology Group
performance status of 0 to 1.

- Estimated life expectancy of at least 12 weeks.

- Recovery from recent therapy (except for alopecia), including chemotherapy,
immunotherapy, biologic therapy, or investigational product. Any such therapy must
have been completed at least 3 weeks before randomization and at least 6 weeks from
use of nitrosourea, or mitomycin.

- Recovery from recent surgery and radiation therapy. At least 1 week since minor
surgery and/or focal/palliative radiation therapy; at least 3 weeks from radiation;
at least 4 weeks from major surgery; and at least 8 weeks from liver resection,
thoracotomy, or neurosurgery.

- Absolute neutrophil count ≥1500/mm^3.

- Hemoglobin ≥9 g/dL.

- Platelets ≥100,000/mm^3.

- Total bilirubin ≤1.5 times the upper limit of normal (ULN).

- Aspartate aminotransferase or alanine aminotransferase ≤2.5*ULN.

- Normal partial thromboplastin time and either international normalized ratio or
prothrombin time <1.5*ULN.

- Serum creatinine ≤1.5*ULN or 24-hour creatinine clearance >60 mL/min.

- Urine dipstick for proteinuria <2+ (negative, trace, or +1). Participants with ≥2+
proteinuria at baseline were to undergo 24-hour urine collection and demonstrate ≤1g
of protein in 24 hours to be eligible.

Exclusion criteria:

- Women of child-bearing potential (WOCBP) unwilling or unable to use an acceptable
method of birth control to avoid pregnancy for the entire study period and up to 6
months after treatment with bevacizumab.

- Women who were pregnant or breastfeeding.

- Women with a positive pregnancy test on enrollment or prior to study drug

- Sexually active fertile men, whose partners were WOCBP, not using an adequate method
of birth control.

- Evidence of baseline sensory or motor neuropathy.

- Serious infection or nonmalignant medical illnesses uncontrolled or the control of
which could be jeopardized by this therapy.

- History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess,
serious gastric ulcer, or bone fracture within 6 months of study entry.

- History of hypertensive crisis or hypertensive encephalopathy.

- Significant vascular disease.

- Clinically significant cardiovascular disease.

- Baseline left ventricular ejection fraction by multiple-gated acquisition scan or
echocardiogram for subjects with prior exposure to anthracyclines not within
institutional normal limits.

- Symptomatic peripheral vascular disease.

- History of high dose chemotherapy with bone marrow transplant or peripheral blood
stem cell transplant within the previous 2 years.

- Evidence of bleeding diathesis or coagulopathy.

- Prior treatment with an epothilone or any antiangiogenic agent.

- Concurrent nonhealing wound, ulcer, or fracture.

- Any current or history of brain and/or leptomeningeal metastases. Psychiatric
disorders or other conditions rendering the participant incapable of complying with
the requirements of the protocol.

- Any concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in
situ of the cervix.

- Known allergy to any of the study drugs or their excipients.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants With Best Tumor Response of Partial Response (PR) or Complete Response (CR) While On-study

Outcome Description:

CR=Disappearance of all clinical and radiologic evidence of target lesions; PR=At least 30% reduction in the sum of the longest diameter of all target lesions.

Outcome Time Frame:

Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

March 2007

Completion Date:

November 2009

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms



University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Weill Medical College of Cornell UniversityNew York, New York  10021
Wilshire Oncology Medical Group, Inc.Rancho Cucamonga, California  91730
Ellis Fischel Cancer CenterColumbia, Missouri  65203
East Valley Hematology and Oncology Medical GroupBurbank, California  91505
Ucsf-Comprehensive Cancer CenterSan Francisco, California  94115