Dose-Dense Doxorubicin, Docetaxel, and Granulocyte Colony-Stimulating Factor Support With or Without Tamoxifen as Preoperative Therapy in Patients With Operable Carcinoma of the Breast: A Randomized, Controlled, Open Phase IIb Study

Abstract

A dose-dense regimen of ADoc with G-CSF offers high compliance, moderate toxicity, and rapid efficacy as a form of preoperative chemotherapy in operable breast cancer. Concurrent treatment with tamoxifen for 8 weeks could not improve the pathologic response rate.

Impact of treatment characteristics on response of different breast cancer phenotypes: pooled analysis of the German neo-adjuvant chemotherapy trials

“…Since availability of HER2 status is a mere function of time and not associated with prognostically important patient or tumor characteristics (Table 2), this restriction is unlikely to have introduced bias. Other unmeasured confounders might be tumor characteristics associated with time, however median tumor size and nodal status in the early Gepardo trial [9] was similar to the most recent GeparQuattro [14] trial.…”

“…Between 1998 and 2006, a total of eight major prospective neoadjuvant trials in 6625 breast cancer patients were conducted in Germany [9,10,11,12,13,14,15,16,17,18]. Details of design and conduct of individual trial were previously reported (Table 1).…”

“…Details of design and conduct of individual trial were previously reported (Table 1). Seven trials were phase III randomized parallel-group trials (6408 patients) [9][10][11][12][13][14][15][16][17] and one was a phase II case series (217 patients) [18] In the GeparTrio main trial [12,13], the 622 non-responders were randomized to 4 further cycles of TAC (321 patients) or 4 cycles of NX (301 patients), whereas the 1390 responders were allocated to 4 or 6 further cycles of TAC (704 and 686 patients, respectively). To avoid confounding by treatment selection according to intermediate clinical assessment of tumor response, we excluded the 334 patients allocated to NX, a proportional random sample of 95 responders, who received a total of 6 cycles of TAC in the GeparTrio pilot trial [11], and the 686 responders, who received a total of 8 cycles of TAC in the GeparTrio main trial [12,13].…”

“…Patients needed to have measurable tumor dimensions either by palpation, sonography or mammography. Locally advanced (cT4a-d) and inflammatory breast cancers were eligible for all trials except GeparDo [9] and GeparDuo [10]. Patients were eligible irrespective of hormone receptor and HER2 receptor status, except in Techno [18], in which only HER2-positive patients were allowed.…”

Response and prognosis after neoadjuvant chemotherapy in 1,051 patients with infiltrating lobular breast carcinoma

“…Between 1998 and 2010, 9,197 breast cancer patients were enrolled in nine prospectively randomized multicentre, neoadjuvant trials in Germany, all having comparable main eligibility criteria [9,11,12].…”