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Bending the Curve Trial by Trial
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NSABP B-14

A randomized clinical trial evaluating tamoxifen in the treatment of patients with node-negative breast cancer who have estrogen-receptor-positive tumors

N = 2,644

Population
Breast cancer with histologically negative axillary nodes and estrogen-receptor-positive tumors (10 fmol or greater)
Design
Randomized, double-blind, placebo-controlled trial of postoperative tamoxifen 10 mg twice a day
Arms
  • Tamoxifen (experimental): Tamoxifen 10 mg twice a day after surgery
  • Placebo (control): Placebo after surgery
People
Fisher B, National Surgical Adjuvant Breast and Bowel Project
Δ 48-month OS+1 pointsΔ DFS+6 points
Show the numbers
Results reported for NSABP B-14
EndpointAnalysisTamoxifenPlaceboEffect
OSprimaryFisher 198993% at 4 y92% at 4 yP=0.3
DFSprimaryFisher 198983%77%P<0.00001The abstract does not state the time point of the 83% vs 77% disease-free survival figures; the preceding sentence of the abstract covers four years of follow-up for survival, and this is not extended to the disease-free survival percentages. The abstract states the treatment-failure rate was reduced by 44 percent in patients aged 49 years or younger.
Results reported for NSABP B-14
EndpointAnalysisTamoxifenPlaceboEffect
OSprimaryFisher 198993% at 4 y92% at 4 yP=0.3
DFSprimaryFisher 198983%77%P<0.00001The abstract does not state the time point of the 83% vs 77% disease-free survival figures; the preceding sentence of the abstract covers four years of follow-up for survival, and this is not extended to the disease-free survival percentages. The abstract states the treatment-failure rate was reduced by 44 percent in patients aged 49 years or younger.
Primary publication: Fisher B, Costantino J, Redmond C, Poisson R, Bowman D, Couture J, et al. A randomized clinical trial evaluating tamoxifen in the treatment of patients with node-negative breast cancer who have estrogen-receptor-positive tumors. N Engl J Med. 1989;320(8):479-84. PubMedDOI

Appears in

Sources

  1. Fisher B, Costantino J, Redmond C, Poisson R, Bowman D, Couture J, et al. A randomized clinical trial evaluating tamoxifen in the treatment of patients with node-negative breast cancer who have estrogen-receptor-positive tumors. N Engl J Med. 1989;320(8):479-84.

    PubMedDOI