Clareo Health | Concomitant Chemoradiotherapy With Weekly Paclitaxel and Vinorelbine and Granulocyte Colony Stimulating Factor (GCSF) Support in Patients With Advanced Breast Cancer
Concomitant Chemoradiotherapy With Weekly Paclitaxel and Vinorelbine and Granulocyte Colony Stimulating Factor (GCSF) Support in Patients With Advanced Breast Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Chicago
With
Amgen
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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:
1. patients with locally advanced unresectable stage IIIa or IIIb;
2. patients with locally recurrent (including locoregional lymph nodes) disease for which curative surgery is not thought possible
3. 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
You may not be if
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
