Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Positive Breast Cancer

Phase 3 Completed 4894 enrolled NSABP Foundation Inc National Cancer Institute (NCI) · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, doxorubicin , cyclophosphamide, paclitaxel, and gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy after surgery may kill any remaining tumor cells. PURPOSE: This randomized phase III trial is studying three different combination chemotherapy regimens and comparing how well they work in treating women who have undergone surgery for node-positive breast cancer.

Timeline

Start: 2004-10
Primary completion: 2012-03
Completion: 2016-06

Outcome

Missed primary endpoint

paper There were no significant differences in 5-year disease-free survival (DFS) between DD AC→PG and DD AC→P (80.6% v 82.2%; HR, 1.07; P = .41) PMID 23940225 ↗

Publications

Swain SM, Tang G, Geyer CE Jr, Rastogi P, Atkins JN, Donnellan PP, Fehrenbacher L, Azar CA, Robidoux A, Polikoff JA, Brufsky AM, Biggs DD, Levine EA, Zapas JL, Provencher L, Northfelt DW, Paik S, Costantino JP, Mamounas EP, Wolmark N. Definitive results of a phase III adjuvant trial comparing three chemotherapy regimens in women with operable, node-positive breast cancer: the NSABP B-38 trial. J Clin Oncol. 2013 Sep 10;31(26):3197-204. doi: 10.1200/JCO.2012.48.1275. Epub 2013 Aug 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cyclophosphamide	Other / unclassified	500 mg/m2	Intravenous
Subject	Cyclophosphamide	Other / unclassified	600 mg/m2	Intravenous
Comparator	Docetaxel	Small molecule	75 mg/m2	Intravenous
Subject	Doxorubicin	Other / unclassified	50 mg/m2	Intravenous
Subject	Doxorubicin	Other / unclassified	60 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	2000 mg/m2	Intravenous
Subject	Paclitaxel	Small molecule	175 mg/m2	Intravenous