December 2nd 2004
The tAnGo trial is a randomized, open-label, multicenter phase IIItrial examining adjuvant treatment with epirubicin (Ellence)/cyclophosphamide(Cytoxan, Neosar) for four cycles followed by paclitaxel aloneor combined with gemcitabine (Gemzar) for four cycles in patients withearly-stage breast cancer. In the Cancer and Leukemia Group B(CALGB) 9344 trial, addition of paclitaxel to anthracycline/cyclophosphamideadjuvant therapy resulted in increased time to recurrence andimproved survival. Because an unplanned subgroup analysis in CALGB9344 indicated a significant benefit of paclitaxel in patients with estrogenreceptor (ER)-negative disease but not ER-positive disease, the initialtAnGo trial design called for enrollment of patients with ER-negativedisease. The tAnGo trial entry criteria were recently amended toallow any ER status, given experience suggesting that clinical benefitof taxane-containing regimens in ER-positive disease may emerge overa time frame longer than that required to detect benefit in ER-negativedisease. Gemcitabine has been included as a partner for paclitaxel inthe tAnGo trial based on high response rates, including high completeresponse rates, observed in phase II trials of the combination in moreadvanced disease and based on the tolerability and safety of the combinationcompared with those of other taxane-containing two-drug combinations.The tAnGo trial is currently accruing patients and has atarget population of 3,000. Trial results should provide important informationon the role of gemcitabine in adjuvant therapy for breastcancer.