HERA, NSABP B-31 & NCCTG N9831 (adjuvant trastuzumab)
Three trials reported together in 2005 showed that a year of trastuzumab after surgery cuts the risk of dying from HER2-positive breast cancer by about a third.
Joint B-31/N9831 analysis: 10-year OS 84% vs 75.2% (HR 0.63), DFS HR 0.60. HERA 11-year: DFS HR 0.76, OS HR 0.74 despite 52% crossover. Turned the worst breast cancer subtype into one of the most curable. HERA also showed 2 years of trastuzumab is no better than 1.
- The treated group had about 40 percent lower chance of the event at any given time (hazard ratio 0.6).
- The absolute difference, how many more people out of 100 were helped, is not reported here.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- 84 vs 75.2 out of 100 alive at 10 years with Chemotherapy + trastuzumab compared with Chemotherapy alone; 8.8 more per 100.
- Roughly one extra person helped for every 11 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Put another way, the treated group had about 37 percent lower chance of the event at any given time (hazard ratio 0.63, likely range 0.54 to 0.73).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: Adjuvant HER2+ early breast cancer: one year of trastuzumab with or after chemotherapy vs chemotherapy alone. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (HER2); the result should not be assumed for people whose cancer does not have it.
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.
9,000 participants enrolled.
Numbers not yet public.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| 10-year overall survival (B-31/N9831) | Chemotherapy + trastuzumab | 2,028 | 84% | 0.63 (0.54–0.73) | — | link |
| Chemotherapy alone | 2,018 | 75.2% | ||||
| Disease-free survival (B-31/N9831)primary | Chemotherapy + trastuzumab | — | — | 0.6 (0.53–0.68) | — | — |
| Chemotherapy alone | — | — |
Pages like this
not linked directly; found by shared links- TrialKATHERINE
Shares Charles E. Geyer Jr., NSABP Foundation, Trastuzumab, HER2-positive breast cancer.
- TrialAPHINITY
Shares David Cameron, Trastuzumab, HER2-positive breast cancer.
- PersonDennis J. Slamon
Shares Barbara Bradfield, Trastuzumab, HER2, HER2-positive breast cancer.
- InstitutionBreast International Group (BIG)
Shares David Cameron, Martine Piccart, Trastuzumab, HER2-positive breast cancer.
- InstitutionInstituto Alexander Fleming
Shares Trastuzumab, HER2, HER2-positive breast cancer.
- InstitutionInstitut Jules Bordet
Shares Martine Piccart, Trastuzumab, HER2-positive breast cancer.
- TrialCLEOPATRA
Shares Trastuzumab, HER2, HER2-positive breast cancer.
- InstitutionGeorgetown Lombardi Comprehensive Cancer Center
Shares Trastuzumab, HER2, HER2-positive breast cancer.