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Bending the Curve Trial by Trial
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Joint analysis of NSABP B-31 and NCCTG N9831: adjuvant chemotherapy with or without concurrent trastuzumab in HER2-positive operable breast cancer

Phase 3NCT00004067NCT00005970

Population
Women with surgically removed HER2-positive breast cancer
Design
Pre-specified joint analysis, added by amendment to two randomised trials (NSABP B-31 and NCCTG N9831), comparing the groups that received chemotherapy without trastuzumab (B-31 group 1 and N9831 group A) with the groups that received trastuzumab concurrently with paclitaxel (B-31 group 2 and N9831 group C); N9831 group B was excluded because trastuzumab was not given concurrently with paclitaxel.
Arms
  • Chemotherapy without trastuzumab (control): Doxorubicin and cyclophosphamide followed by paclitaxel (every 3 weeks in B-31, weekly in N9831)
  • Chemotherapy with concurrent trastuzumab (experimental): Doxorubicin and cyclophosphamide followed by paclitaxel, with 52 weeks of trastuzumab beginning with paclitaxel
People
Romond EH
DFSHR 0.48
Show the numbers
Results reported for Joint analysis of NSABP B-31 and NCCTG N9831: adjuvant chemotherapy with or without concurrent trastuzumab in HER2-positive operable breast cancer
EndpointAnalysisChemotherapy with concurrent trastuzumabChemotherapy without trastuzumabEffect
DFSJoint analysis (B-31 and N9831 combined)Events: recurrence, second primary cancer, or death before recurrenceinterimRomond 2005——HR 0.48P<0.0001First scheduled interim analysis (data to 15 March 2005): 394 events, 133 in the trastuzumab group and 261 in the control group; crossed the early stopping boundary. Absolute disease-free survival difference of 12 percent at three years (arm values not stated in the abstract). No confidence interval is given in the abstract.
Results reported for Joint analysis of NSABP B-31 and NCCTG N9831: adjuvant chemotherapy with or without concurrent trastuzumab in HER2-positive operable breast cancer
EndpointAnalysisChemotherapy with concurrent trastuzumabChemotherapy without trastuzumabEffect
DFSJoint analysis (B-31 and N9831 combined)Events: recurrence, second primary cancer, or death before recurrenceinterimRomond 2005——HR 0.48P<0.0001First scheduled interim analysis (data to 15 March 2005): 394 events, 133 in the trastuzumab group and 261 in the control group; crossed the early stopping boundary. Absolute disease-free survival difference of 12 percent at three years (arm values not stated in the abstract). No confidence interval is given in the abstract.
Primary publication: Romond EH, Perez EA, Bryant J, Suman VJ, Geyer CE Jr, Davidson NE, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005;353(16):1673-84. PubMedDOI

Appears in

Sources

  1. Romond EH, Perez EA, Bryant J, Suman VJ, Geyer CE Jr, Davidson NE, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005;353(16):1673-84.

    PubMedDOI