Predicting Response and Toxicity in Patients Receiving Paclitaxel and Avastin for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study
- Histologically or cytologically confirmed adenocarcinoma of the breast with
measurable locally recurrent, locally advanced (that is not amenable to resection
with curative intent), or metastatic disease.
- Patients must consent to have a biopsy performed to obtain fresh tissue or be able to
identify a FFPE tissue block in which tissue samples can be obtained to complete the
testing for this study.
- Planned chemotherapy regimen of paclitaxel and Avastin for the treatment of
metastatic breast cancer.
- Females age > 18 years
- Written informed consent and HIPAA authorization for release of personal health
- Patients must not have had chemotherapy for locally recurrent or metastatic breast
- Hormonal therapy for locally recurrent or metastatic disease must have been
discontinued at least 2 weeks prior to study entry.
- Patients must not have had adjuvant or neoadjuvant taxane therapy within 12 months
prior to study entry.
- Breast cancer overexpressing HER-2 (gene amplification by FISH or 3+ overexpression
by immunohistochemistry) are not eligible unless they have received prior therapy
- Patients must not have had a major surgical procedure within 4 weeks prior to study
entry. (Placement of vascular access device, and breast biopsy, will not be
considered major surgery.)
- Patients must not have had a minor surgical procedure, placement of an access device,
or fine needle aspiration within 7 days of starting protocol therapy.
- Patients must not have had radiation within 2 weeks prior to study entry.
- Previously radiated area(s) must not be the only site of disease for study entry.
- Patients must not have a history of bleeding diathesis or have used anticoagulant
therapy within 10 days of study entry. (Low dose anticoagulant therapy to maintain
patency of a vascular access device is allowed.)
- Patients with a history of deep vein thrombosis or pulmonary embolism are not
- Aspirin usage (> 325 mg/day) or other nonsteroidal anti-inflammatory medications
known to inhibit platelet function daily are not allowed within 10 days prior to
- Patients currently using any of the following drugs known to inhibit platelet
function are not eligible: dipyridamole (Persantine), ticlopidine (Ticlid),
clopidogrel (Plavix) and cilostazol (Pletal).
- Patients must not have a history of TIA or CVA within 6 months prior to study entry.
- Patients must not have a history or radiologic evidence of CNS metastases including
previously treated, resected or asymptomatic brain lesions or leptomeningeal
involvement (head CT or MRI must be obtained within 6 weeks prior to study entry).
- Patients must not have a non-healing wound or fracture.
- Patients must not have a hypersensitivity to paclitaxel or drugs using the vehicle
Cremophor, Chinese hamster ovary cell products or other recombinant human antibodies.
- Females must not be pregnant or breastfeeding. Females of childbearing potential must
use an accepted and effective method of contraception (hormonal or barrier method of
birth control; abstinence) while on treatment and for a 3 month period thereafter.
- Females of childbearing potential must have a negative pregnancy test within 7 days
prior to being registered for protocol therapy. Subjects are considered not of
child bearing potential if they are surgically sterile (they have undergone a
hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to study entry
- Urine protein: creatinine (UPC) ratio > 1.0 at baseline or urine protein dipstick >