Ixabepilone in Treating Participants With Significant Residual Disease of HER2/Neu Negative Invas… (NCT00877500) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Ixabepilone in Treating Participants With Significant Residual Disease of HER2/Neu Negative Invasive Breast Cancer After Systemic Therapy
United States116 participantsStarted 2009-03-30
Plain-language summary
This phase II trial studies how well ixabepilone compared with standard of care works in treating patients with HER2/Neu negative breast cancer that remains after undergoing systemic therapy. Ixabepilone works by blocking cell division which may cause cancer cell death.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with histologic confirmation of invasive HER2/neu-negative breast cancer (immunohistochemistry \[IHC\] 0-1+ or fluorescence in situ hybridization \[FISH\]-negative) that have received complete anthracycline and taxane neoadjuvant systemic therapy and that at the time of surgery are expected to have significant residual disease. Therapy should include at least 4 cycles of an anthracycline-based regimen (adriamycin-cytoxan \[AC\], 5-fluorouracil/adriamycin/intravenous \[IV\] cyclophosphamide \[FAC\], fluorouracil-epirubicin-IV cytoxan \[FEC\]) and 12 weeks of a taxane-based regimen (weekly paclitaxel, every 3-week docetaxel).
* Patients who did not complete therapy due to disease progression are eligible.
* Patients with bilateral breast cancers are eligible.
* Patients should have a Karnofsky performance scale of \>= 70%.
* Peripheral granulocyte count of \>= 1500/mm\^3.
* Platelet count \>= 100000 mm\^3.
* Bilirubin within normal laboratory values.
* Alkaline phosphatase may be up to 1.5 x upper limit of normal (ULN) of the institution.
* Transaminases (alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\]) may be up to 1.5 x upper limit of normal (ULN) of the institution.
* Creatinine levels within normal range.
* Negative serum pregnancy test for a woman of childbearing potential.
* Women of childbearing potential (WOCP) must use a reliable and appropriate contraceptive method during the study and 6 months after chemotherapy…
What they're measuring
1
Genomic (transcriptional profiles) and proteomic (pathway activation) features that distinguish tumors