Concomitant Chemoradiotherapy With Weekly Paclitaxel and Vinorelbine and Granulocyte Colony Stimulating Factor (GCSF) Support in Patients With Advanced Breast Cancer

Inclusion criteria

• Histologically or cytologically confirmed adenocarcinoma of the male or female breast (male or female) with gross, uncontrolled, unresectable breast and/or chest wall disease including:

• patients with locally advanced unresectable stage IIIa or IIIb;
• patients with locally recurrent (including locoregional lymph nodes) disease for which curative surgery is not thought possible
• patients with metastatic disease AND uncontrolled locoregional disease are eligible.
• Prior chemotherapy allowed, except for nitrosoureas and mitomycin chemotherapy or high dose chemotherapy with marrow or stem cell rescue.
• Prior palliative radiation to sites of metastases allowed (i.e. bone, brain, lung)
• 4 weeks since any prior treatments (excluding hormonal therapy). Concurrent hormonal therapy is not allowed.
• Aged 18 years or older
• CALGB performance status of 0 - 2
• Life expectance of at least 12 weeks
• Initial Laboratory Data:

• ANC Count > 1500/mm3
• Platelet Count > 100,000/mm3
• Creatine ≤ 2.0 mg/dl
• Bilirubin ≤ 1.5 mg/dl
• ALT (SGPT) ≤ 3 times the upper limit of normal
• Signed informed consent

Exclusion criteria

• Prior breast or chest wall radiation is not allowed unless the proposed site radiation port does not overlap with prior ports
• Subjects must not be pregnant (females able to have children must have negative pregnancy test and agree to use adequate contraception)
• Patients with a documented hypersensitivity to E.coli derived proteins are excluded.
• No other serious medical condition such as uncontrolled infection that in the opinion of the investigators places patient at undue risk for study treatment