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A Randomized Phase III Trial of Weekly Paclitaxel Compared to Weekly Nanoparticle Albumin Bound Nab-Paclitaxel or Ixabepilone With or Without Bevacizumab as First-line Therapy for Locally Recurrent or

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Trial Conditions
  • Estrogen Receptor-negative Breast Cancer
  • Estrogen Receptor-positive Breast Cancer
  • HER2-negative Breast Cancer
  • HER2-positive Breast Cancer
  • Male Breast Cancer
  • Progesterone Receptor-negative Breast Cancer
  • Progesterone Receptor-positive Breast Cancer
  • Recurrent Breast Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer
What is the purpose of this trial?

This randomized phase III trial is studying different chemotherapy regimens with or without bevacizumab and their side effects and comparing how well they work in treating patients with stage IIIC or stage IV breast cancer. Drugs used in chemotherapy, such as paclitaxel, paclitaxel albumin-stabilized nanoparticle formulation, and ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known which treatment regimen is more effective in treating patients with breast cancer

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

Inclusion Criteria:

- Histologically confirmed invasive breast cancer

- Stage IIIC or IV (locally recurrent or metastatic) disease not amenable to local
therapy

- Measurable disease (target lesions), defined as ≥ 1 lesion that can be accurately
measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 2.0 cm with
conventional techniques or as ≥ 1 cm with spiral CT scan

- No non-measurable lesions, including any of the following:

- Ascites

- Pleural/pericardial effusion

- Inflammatory breast disease

- Lymphangitis cutis/pulmonitis

- Bone lesions

- Leptomeningeal disease

- Cystic lesions

- Abdominal masses not confirmed and followed by imaging techniques

- HER2/neu status must be known

- HER2-positive disease allowed provided patient received prior trastuzumab
(Herceptin®) or lapatinib (documentation of progression on HER2-directed therapy
is not required)

- No progressing or untreated CNS metastases or leptomeningeal disease

- History of resected brain metastases with stable MRI scans for 3 months,
including within the past 4 weeks allowed

- History of gamma-knife radiosurgery or whole-brain radiation with stable MRI
scans for 3 months, including within the past 4 weeks allowed

- Hormone receptor status must be known

- Estrogen receptor (ER)- and progesterone receptor (PgR)-positive if ≥ 1% cells
are positive

- Menopausal status not specified

- ECOG (Zubrod) performance status 0-1

- Life expectancy ≥ 12 weeks

- Granulocytes ≥ 1,500/μL

- Platelet count ≥ 100,000/μL

- Creatinine ≤ 2.0 mg/dL

- Bilirubin < 1.5 mg/dL (unless due to Gilbert's syndrome)

- AST and ALT ≤ 2.5 times upper limit of normal

- Urine protein ≤ 1+ OR urine protein: creatinine ratio < 1

- Patients with proteinuria ≥ 2+ at baseline must undergo a 24-hoururine
collection that demonstrates < 1 g of protein/24 hr or UPC ratio ≤ 1

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- History of seizures allowed if well controlled with standard medication

- No history of hypersensitivity to paclitaxel or Cremophor® EL CTCAE grade ≥ 3

- No other active malignancy except nonmelanoma skin cancer (patients are not
considered to have a "currently active" malignancy if they have completed therapy and
are considered by their physician to have less than 30% risk of relapse)

- No history of abdominal fistula or intra-abdominal abscess within 6 months prior to
study registration

- No history of gastrointestinal (GI) perforation within the past 12 months

- No history of significant bleeding episodes (e.g., hemoptysis, upper or lower GI
bleeding) within the past 6 months

- No history of stroke or transient ischemic attack within the past 6 months

- No history of clinically significant cardiovascular disease including any of the
following:

- Uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg
and/or diastolic BP > 90 mm Hg on antihypertensive medications

- Prior history of hypersensitivity or hypertensive encephalopathy

- History of myocardial infarction or unstable angina within past 6 months

- NYHA congestive heart failure class II-IV

- Symptomatic peripheral vascular disease

- Significant vascular disease (e.g., aortic aneurysm or aortic dissection) or
arterial thrombotic events

- No serious, non-healing wound, ulcer, or bone fracture

- No significant traumatic injury in the past 28 days

- No peripheral neuropathy ≥ grade 2

- Concurrent full-dose anticoagulants allowed but patient must be on a stable dose of
warfarin or low molecular weight heparin

- Anti-platelet therapy or on daily prophylactic-dose aspirin allowed

- Stable doses of anticoagulation for atrial fibrillation allowed

- No prior chemotherapy regimen for metastatic disease

- Adjuvant or neoadjuvant taxane allowed provided interval between completion of
adjuvant therapy and disease recurrence is ≥ 12 months

- At least 2 weeks since prior radiotherapy

- At least 28 days since prior major surgical procedure or open biopsy and fully
recovered

- There are no restrictions on core biopsies, placement of a vascular access
device, or other minor procedures prior to registration.

- At least 7 days since prior hormonal therapy

- Any number of prior hormonal therapies allowed

- Prior trastuzumab or lapatinib ditosylate for HER2-overexpressing tumors allowed

- Prior bevacizumab allowed

- Prior and concurrent bisphosphonate treatment allowed

- No concurrent major surgical procedure

- No concurrent palliative radiotherapy

- No concurrent aprepitant

- No concurrent pegfilgrastim

- No other concurrent chemotherapy or anticancer hormone therapy

Gender: Both
Steward Physician(s)
  • Hope Rugo
Trial Interventions
Biological
  • bevacizumab
Drug
  • paclitaxel
  • paclitaxel albumin-stabilized nanoparticle formulation
  • ixabepilone
Other
  • questionnaire administration
  • laboratory biomarker analysis
Physician Researcher

Investigator Name:

  • Hope Rugo

Other Information

Sponsor: National Cancer Institute (NCI)
Phase: Phase 3
Trial ID: NCT00785291
Volunteers:  Not Accepting Healthy Volunteers

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