Phase II study of preoperative systemic treatment with the combination of docetaxel and trastuzumab in patients with locally advanced HER-2-overexpressing breast cancer.

Abstract

We conducted a phase II study using docetaxel and trastuzumab as preoperative systemic treatment for locally advanced HER-2-overexpressing breast cancer (stage IIIB or IIIC) to evaluate the efficacy and safety, and to perform a subset analysis based on tumor biomarkers. Patients received 4 mg/kg trastuzumab on day 1, followed by weekly treatments of 2mg/kg, in addition to 75 mg/m(2) docetaxel every 3 weeks for 4 cycles before surgery. The primary end point was clinical response rate measured by MRI or CT. Twenty-five patients were enrolled. The median age was 54 years and median tumor size was 63 mm. The overall clinical response rate was 68% [95% CI: 47-85%] and the pCR rate was 22% [95% CI: 8-44%]. The clinical response and the pCR rates of patients with ER- and PgR- tumors were 79% and 31%, respectively, while they were 55% and 10%, respectively, in the patients with ER+ and/or PgR+ tumors (p=0.34, p=0.34, respectively). Cardiac toxicity was well tolerated; there was no evidence of clinical cardiac events in any patient. The combination of docetaxel and trastuzumab produced highly favorable clinical and pathological responses for locally advanced HER-2-overexpressing breast cancer. Subgroup analysis suggests that ER/PgR negative tumors might be associated with pathological response in locally advanced breast cancer.

• Authors: Masataka Sawaki, Hiroji Iwata, Yasuyuki Sato, Masaki Wada, Tatsuya Toyama, Eiichi Sasaki, Yasushi Yatabe, Tsuneo Imai, Yasuo Ohashi
• Journal: Breast (Edinburgh, Scotland) (Breast) Vol. 19 Issue 5 Pg. 370-6 (Oct 2010) ISSN: 1532-3080 [Electronic] Netherlands
• PMID: 20472435 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2010 Elsevier Ltd. All rights reserved.

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Biomarkers, Tumor
• Taxoids
• Docetaxel
• ERBB2 protein, human
• Receptor, ErbB-2
• Trastuzumab

Topics

• Adult
• Aged
• Antibodies, Monoclonal (administration & dosage, adverse effects)
• Antibodies, Monoclonal, Humanized
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Biomarkers, Tumor (metabolism)
• Breast Neoplasms (drug therapy, metabolism, pathology, surgery)
• Chemotherapy, Adjuvant
• Docetaxel
• Female
• Humans
• Middle Aged
• Neoplasm Staging
• Receptor, ErbB-2 (metabolism)
• Taxoids (administration & dosage, adverse effects)
• Trastuzumab
• Treatment Outcome