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Phase II Feasibility Trial Incorporating Bevacizumab Into Dose Dense Doxorubicin and Cyclophosphamide Followed by Paclitaxel in Patients With Lymph Node Positive Breast Cancer

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Trial Conditions
  • Breast Cancer
What is the purpose of this trial?

This phase II trial is studying how well giving bevacizumab together with combination chemotherapy works in treating patients who have undergone surgery for breast cancer that has spread to the lymph nodes. 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with more than one chemotherapy drug (combination chemotherapy), may be a better way to block tumor growth.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the breast

- Node-positive disease in 1 or more axillary or internal mammary lymph node by
histology with hematoxylin and eosin staining

- Has undergone prior definitive breast surgery including total mastectomy and axillary
dissection (modified radical mastectomy), total mastectomy and sentinel node biopsy,
lumpectomy and axillary dissection or lumpectomy and sentinel node biopsy within the
past 29-84 days (arm A only)

- Surgical margins must be histologically free of invasive tumor and ductal
carcinoma in situ, but lobular carcinoma in situ allowed

- Synchronous bilateral breast cancer diagnosed within the past month allowed provided
the higher TNM (Tumor,Node,Metastasis) stage tumor meets study eligibility criteria

- Age>=18

- ECOG performance status of 0-2

- Adequate organ function as evidenced by following, obtained within 8 weeks prior to
registration:

- Absolute neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 100,000/mm^3

- Bilirubin ≤ 1.5 mg/dL

- Aspartate aminotransferase (AST) ≤ 2 times upper limit normal (ULN)

- Prothrombin time international normalized ratio (PT INR) ≤ 1.5 times normal

- Partial thromboplastin time (PTT) ≤ 1.5 times normal

- Creatinine ≤ 1.5 mg/dL

- Urine protein:creatinine ratio < 1.0

- Left ventricular ejection fraction (LVEF) normal by multi gated acquisition scan
(MUGA) or echocardiogram (ECHO)

- Fertile patients must use effective contraception during and for 3-4 months after
completion of study treatment

- Prior tamoxifen or raloxifene for chemoprevention allowed

- More than 4 weeks since prior major surgery

- Non-operative biopsy or placement of a vascular access device is not considered
major surgery

- Regular use of cyclo-oxygenase-2 inhibitors or low-dose aspirin allowed

Exclusion Criteria:

- With immunohistologic staining as the only evidence of nodal involvement

- Her2/neu-positive disease(i.e.,3+ by immunohistochemistry or positive by fluorescent
in situ hybridization)

- Clinical evidence of inflammatory disease or fixed axillary nodes (N2)

- History of myocardial infarction within the past year

- History of unstable angina within the past year

- History of arterial thrombotic events within the past year

- Uncontrolled or clinically significant arrhythmia

- New York Heart Association grade II-IV congestive heart failure

- Peripheral vascular disease ≥ grade II

- Uncontrolled hypertension, defined as systolic blood pressure (BP)>160 mm Hg or
diastolic BP>90 mm Hg

- History of deep venous thrombosis

- History of cerebrovascular disease, including transient ischemic attack or stroke

- Other clinically significant cardiovascular disease

- History of pulmonary embolism

- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
the past 6 months

- Non-healing wound or bone fracture

- Hypersensitivity to paclitaxel or drugs using Cremophor

- Hypersensitivity to Chinese hamster ovary cell products or other recombinant human
antibodies

- Pregnant

- Nursing during and for ≥ 3-4 months after completion of study treatment

- Prior cytotoxic chemotherapy for breast cancer

- Prior anthracycline, anthracenedione, or taxane for any condition

- Prior hormonal therapy for breast cancer

- Other concurrent tamoxifen or raloxifene

- Prior radiotherapy for breast cancer

- Concurrent radiotherapy to the internal mammary chain

- Concurrent therapeutic anticoagulants

- Concurrent prophylactic use of anticoagulants to maintain patency of vascular
assess device allowed

- Concurrent regular use of aspirin (i.e., daily for ≥ 10 days at doses of > 325
mg/day) or regular therapeutic doses of other nonsteroidal anti-inflammatory drugs
known to inhibit platelet function

- Other concurrent drugs known to inhibit platelet function, including any of the
following:

- Dipyridamole

- Ticlopidine

- Clopidogrel

- Cilostazol

- Concurrent cardioprotectant agents

Gender: Both
Steward Physician(s)
  • Kathy Miller, MD
Facilities
  • Morton Hospital - Completed
Trial Interventions
Biological
  • bevacizumab
  • filgrastim
  • pegfilgrastim
Drug
  • cyclophosphamide
  • doxorubicin hydrochloride
  • paclitaxel
Physician Researcher

Investigator Name:

  • Kathy Miller, MD

Other Information

Sponsor: National Cancer Institute (NCI)
Phase: Phase 2
Trial ID: NCT00119262
Volunteers:  Not Accepting Healthy Volunteers

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