Phase II study of dose-dense sequential doxorubicin and docetaxel for patients with advanced operable and inoperable breast cancer

Brenda W. Cooper, Tomas Radivoyevitch, Beth A. Overmoyer, Robert R. Shenk, Huong T. Pham, Judith R. Samuels, Margaret P. Parry, Paula Silverman

Research output: Contribution to journalArticlepeer-review

12 Scopus citations


Rapid sequential delivery of doxorubicin 75 mg/m2 q 2 weeks×3 cycles followed by docetaxel 100 mg/m2 q 2 weeks×3 cycles, with filgrastim support was evaluated in patients with inoperable and large operable breast cancers who were not initially candidates for breast conservation therapy. Postoperative CMF chemotherapy and/or radiation were administered based on surgical findings. Median age of the 39 enrolled patients was 47 (range 27-59), stage IIA (6 patients), IIB (14 patients), IIIA (10 patients), IIIB (9 patients), and 23 patients (59%) had clinical nodal involvement. The average bidimensional tumor size before treatment was 30 cm2. Clinical responses included 13 (33%) complete responses, 23 (59%) partial responses, 1 stable disease, and 2 progressive disease, for an overall response rate of 92%. Clinical response rate was 11/13(85%) in HER2/neu positive patients compared to 25/26 (96%) in tumors that did not express HER2/neu. Twenty patients (51%) underwent breast conservation surgery. Pathologic tumor response at the time of definitive surgery included 4 pathologic CR (pCR, 10%), 4 microscopic invasion (pINV), and 14 (36%) pathologically negative axillary nodes. pCR was not observed in any HER2/neu positive patients. 5/39 patients were unable to complete all cycles of docetaxel and 8 patients required dose reduction of docetaxel due to development of grade 3-4 mucositis and hand-foot syndrome. This observation prompted a protocol change requiring 3 weeks between doxorubicin and docetaxel. Primary chemotherapy with dose-dense doxorubicin and docetaxel given sequentially is well tolerated and allows a high rate of breast sparing in patients with large breast cancers.

Original languageEnglish (US)
Pages (from-to)311-318
Number of pages8
JournalBreast cancer research and treatment
Issue number3
StatePublished - Jun 2006


  • Breast conservation
  • Her2/neu expression
  • Primary chemotherapy

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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