Paclitaxel With or Without Trastuzumab in Treating Women With Inoperable, Recurrent, or Metastatic Breast Cancer With or Without Overexpression of HER2/Neu

This study has been completed.

Study NCT00003440 Information provided by Cancer and Leukemia Group B

First Received: November 1, 1999 Last Updated: June 21, 2011 History of Changes

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Study Status:	This study has been completed.
Study Completion Date:	April 2009
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Publications:

Rimm DL, Broadwater G, Friedman P, et al.: Uniformly positive (>80%) HER2 expression maximizes sensitivity and specificity for prediction of response to trastuzumab in CALGB 9840. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-6046, 2008.

Seidman AD, Berry D, Cirrincione C, Harris L, Muss H, Marcom PK, Gipson G, Burstein H, Lake D, Shapiro CL, Ungaro P, Norton L, Winer E, Hudis C. Randomized phase III trial of weekly compared with every-3-weeks paclitaxel for metastatic breast cancer, with trastuzumab for all HER-2 overexpressors and random assignment to trastuzumab or not in HER-2 nonoverexpressors: final results of Cancer and Leukemia Group B protocol 9840. J Clin Oncol. 2008 Apr 1;26(10):1642-9.

Naughton MJ, Gu L, Wang XF, et al.: Quality of life (QOL) companion to CALGB 9840: a phase III study of paclitaxel (P) via weekly 1 hour (hr) versus standard 3 hour infusion every 3 weeks with trastuzumab in the treatment of patients with/without HER-2/neu-overexpressing metastatic breast cancer. [Abstract] J Clin Oncol 24 (Suppl 18): A-674, 2006.

Seidman AD, Broadwater G, Carney W, et al.: Serum HER2 extracellular domain (ECD) levels and efficacy of weekly (W) or every 3-weekly (q3W) paclitaxel (P) with or without trastuzumab (T) in patients (pts) with metastatic breast cancer (MBC): CALGB 150002/9840. [Abstract] J Clin Oncol 23 (Suppl 16): A-558, 18s, 2005.

Seidman AD, Berry D, Cirrincione C, et al.: CALGB 9840: phase III study of weekly (W) paclitaxel (P) via 1-hour(h) infusion versus standard (S) 3h infusion every third week in the treatment of metastatic breast cancer (MBC), with trastuzumab (T) for HER2 positive MBC and randomized for T in HER2 normal MBC. [Abstract] J Clin Oncol 22 (Suppl 14): A-512, 6s, 2004.