A Phase II Clinical Trial of Weekly Paclitaxel and Carboplatin in Combination With Panitumumab in Metastatic Breast Cancer Patients With Triple Negative Disease

Inclusion Criteria

Inclusion

- Pathologically confirmed invasive breast cancer with ER < 10%, PR < 10%, by IHC, HER2
1+ or 0 or FISH negative

- Measurable (>= 1 cm) or assessable disease detectable by imagining or physical exam

- Patients with bone only disease have measurable lesions on x-ray, MRI, or CT scan

- Only one or no prior therapy for metastatic or recurrent breast cancer is allowed

- Prior chemotherapy or radiation therapy is permitted but at least 2 weeks should
elapse prior to study enrollment

- Prior therapy with bevacizumab is permitted but at least 2 weeks should elapse prior
to study enrollment

- Prior therapy with bevacizumab is permitted but at least 28 days should elapse from
the last bevacizumab treatment prior to study enrollment

- ECOG PS or 0-1

- Signed protocol specific informed consent prior to registration

- Life expectancy greater than 3 months

- Please contact study investigator and/or consult the protocol document for specific
laboratory criteria

- Tissue block available from primary breast cancer

- Premenopausal women must have a negative serum or urine pregnancy test prior to
starting on study treatment (post-menopausal is defined as > 6 months of amenorrhea
prior hysterectomy)

Exclusion

- More than or equal to 2 prior regimens for metastatic breast cancer

- Leptomeningeal disease

- Brain metastasis except for a solitary lesion that was resected or treated with gamma
knife with no residual disease on CT or MRI or received whole brain RT and f/u MRI
was normal with no residual neurologic deficit

- History of interstitial lung disease (ie pneumonitis, pulmonary fibrosis) or evidence
of interstitial lung disease on baseline chest computerized tomography (CT) scan

- History of irreversible neuropathy

- Another malignancy other than carcinoma in situ of the cervix or skin cancer

- Active uncontrolled bacterial viral or fungal infection

- Active pregnancy or breast feeding

- Patients with pre-existing neuropathy >= grade 2

- History of myocardial infarction, symptomatic congestive heart failure, unstable
angina pectoris, or cardiac arrhythmia

- Patients with previous history of CTCAE grade >= 3 hypersensitivity to paclitaxel or
Cremophor EL are not eligible