Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
G-CSF · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Weekly doxorubicin (24 mg/m2 IV) with daily oral cyclophosphamide (60 mg/m2 PO) for 12 weeks with G-CSF support days 2 - 7 of each week followed by weekly paclitaxel (80 mg/m2 IV) for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Paclitaxel | DRUG | 80 mg/m2 IV for 12 weeks following completion of doxorubicin and cyclophosphamide |
| Doxorubicin | DRUG | 24 mg/m2 IV weekly x 12 |
| Cyclophosphamide | DRUG | 60 mg/m2 PO daily for 12 weeks |
| G-CSF | DRUG | 5 mcg per kg subcutaneously days 2 - 7 during doxorubicin and cyclophosphamide for 12 weeks |
Inclusion Criteria: * Patient must have a histologically confirmed diagnosis of primary breast carcinoma that has been surgically resected. (This regimen is not intended for neoadjuvant treatment.) * The attending physician must judge the patient to be an appropriate candidate for Adriamycin based ...
G-CSF is being studied for use in breast neoplasm, specifically as part of an adjuvant therapy regimen for high-risk breast cancer. It is given weekly alongside Adriamycin and oral Cytoxan for 12 weeks, followed by weekly Taxol for 12 weeks. The drug is intended to support patients undergoing this chemotherapy treatment.
G-CSF is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. Amgen is conducting clinical research on this drug for the treatment of breast neoplasm.
G-CSF is in Phase 2 clinical development. It is an investigational drug for breast neoplasm and has not yet been approved for this use. The Phase 2 trial has been completed, and the drug remains under clinical investigation.
G-CSF has one completed clinical trial, identified as NCT00194753. This Phase 2 trial enrolled 80 participants with breast neoplasm in the United States. The study was uncontrolled, meaning there was no comparison group, and it was not randomized or double-blinded.
G-CSF is a granulocyte colony-stimulating factor, and it is commonly known by the generic name filgrastim. In the context of this clinical trial, G-CSF is used as a supportive therapy to help manage the side effects of chemotherapy in patients with high-risk breast cancer.