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The trial that took the radical out of radical mastectomy. Removing the chest muscles and clearing every node did not help women live longer, and neither did removing nodes that had cancer in them but were not causing trouble. It is the first evidence that breast cancer spreads early through the bloodstream rather than marching outward node by node.
NSABP B-04 opened in 1971 to test William Halsted's theory directly. 1,079 women with clinically negative axillary nodes were randomised three ways, to radical mastectomy, to total mastectomy with postoperative irradiation, or to total mastectomy with axillary dissection only if nodes later became positive. A further 586 women with clinically positive nodes were randomised to radical mastectomy or to total mastectomy with irradiation.
At twenty-five years there were no significant differences among any of the groups in disease-free survival, relapse-free survival, distant-disease-free survival or overall survival. Among node-negative women, the hazard ratio for death after total mastectomy with radiation against radical mastectomy was 1.08 (95 percent confidence interval 0.91 to 1.28, p=0.38), and after total mastectomy without radiation 1.03 (0.87 to 1.23, p=0.72). Among node-positive women it was 1.06 (0.89 to 1.27, p=0.49).
The result that matters most is the one about the axilla, and the authors state it plainly: the findings fail to show a significant survival advantage either from removing occult positive nodes at the initial operation or from irradiating them. Differences of a few percentage points cannot be excluded, which is the honest limit of the trial. Every subsequent axillary de-escalation trial, from NSABP B-32 to Z0011 to SENOMAC, is a refinement of the question B-04 asked first.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
1,665 randomised.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Death from any cause at 25 years, node-negative women: total mastectomy with radiation against radical mastectomyprimary | Total mastectomy with irradiation against radical mastectomy | - | 1.08 hazard ratio | 1.08 (0.91 to 1.28) | 0.38 | link |
| Death from any cause at 25 years, node-negative women: total mastectomy alone against radical mastectomy | Total mastectomy alone against radical mastectomy | - | 1.03 hazard ratio | 1.03 (0.87 to 1.23) | 0.72 | link |
| Death from any cause at 25 years, node-positive women | Total mastectomy with irradiation against radical mastectomy | - | 1.06 hazard ratio | 1.06 (0.89 to 1.27) | 0.49 | link |
Shares NSABP B-32, Doing less to the armpit, Lymphadenectomy (lymph node dissection), HER2-positive breast cancer.
Shares Breast conservation or mastectomy, NSABP B-06, Mastectomy, Lymphadenectomy (lymph node dissection).
Shares Breast conservation or mastectomy, NSABP B-06, Mastectomy, HER2-positive breast cancer.
Shares ACOSOG Z0011 (Alliance), Doing less to the armpit, Lymphadenectomy (lymph node dissection), HER2-positive breast cancer.
Shares ACOSOG Z0011 (Alliance), Doing less to the armpit, Lymphadenectomy (lymph node dissection), HER2-positive breast cancer.
Shares NSABP B-32, Doing less to the armpit, HER2-positive breast cancer, Breast cancer (all types).
Shares NSABP B-32, ACOSOG Z0011 (Alliance), Doing less to the armpit, Lymphadenectomy (lymph node dissection).
Shares ACOSOG Z0011 (Alliance), Doing less to the armpit, Lymphadenectomy (lymph node dissection), HER2-positive breast cancer.