drugset / Trial / NCT00066443
Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer
NaSingle-groupOpen-labelTreatment
Summary
RATIONALE: Drugs used in chemotherapy such as epirubicin and docetaxel use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as pegfilgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase I/II trial to study the effectiveness of combining epirubicin and docetaxel with pegfilgrastim in treating women who have locally advanced or inflammatory breast cancer.
Timeline
- Start
- 2003-11-03
- Primary completion
- 2010-01-06
- Completion
- 2014-01-16
Publications
- Results Parissenti AM, Chapman JA, Kahn HJ, Guo B, Han L, O'Brien P, Clemons MP, Jong R, Dent R, Fitzgerald B, Pritchard KI, Shepherd LE, Trudeau ME. Association of low tumor RNA integrity with response to chemotherapy in breast cancer patients. Breast Cancer Res Treat. 2010 Jan;119(2):347-56. doi: 10.1007/s10549-009-0531-x.
- Results Trudeau ME, Chapman JA, Guo B, Clemons MJ, Dent RA, Jong RA, Kahn HJ, Pritchard KI, Han L, O'Brien P, Shepherd LE, Parissenti AM. A phase I/II trial of epirubicin and docetaxel in locally advanced breast cancer (LABC) on 2-weekly or 3-weekly schedules: NCIC CTG MA.22. Springerplus. 2015 Oct 21;4:631. doi: 10.1186/s40064-015-1392-x. eCollection 2015.
- Parissenti AM, Guo B, Pritzker LB, Pritzker KP, Wang X, Zhu M, Shepherd LE, Trudeau ME. Tumor RNA disruption predicts survival benefit from breast cancer chemotherapy. Breast Cancer Res Treat. 2015 Aug;153(1):135-44. doi: 10.1007/s10549-015-3498-9. Epub 2015 Jul 25.
- Pritzker K, Pritzker L, Generali D, Bottini A, Cappelletti MR, Guo B, Parissenti A, Trudeau M. RNA Disruption and Drug Response in Breast Cancer Primary Systemic Therapy. J Natl Cancer Inst Monogr. 2015 May;2015(51):76-80. doi: 10.1093/jncimonographs/lgv015.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 50 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 85 mg/m2 | Intravenous |
| Subject | Epirubicin | Small molecule | 50 mg/m2 | Intravenous |
| Subject | Epirubicin | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Epirubicin | Small molecule | 90 mg/m2 | Intravenous |
| Subject | Epirubicin | Small molecule | 120 mg/m2 | Intravenous |
| Background | Pegfilgrastim | Protein / enzyme biologic | 6 mg | Subcutaneous |