HER2CLIMB
The first trial to prove a drug helps HER2-positive brain metastases, extending survival by four and a half months overall.
PFS 7.8 vs 5.6 months (HR 0.54); OS 21.9 vs 17.4 months (HR 0.66; final 24.7 vs 19.2, HR 0.73). In patients with brain metastases (48%), CNS-PFS HR 0.32 and OS 18.1 vs 12.0 months. Approved April 2020.
- Median 7.8 vs 5.6 months with Tucatinib arm compared with Placebo arm; about 2.2 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 46 percent lower chance of the event at any given time (hazard ratio 0.54, likely range 0.42 to 0.71).
- 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.
- Median 21.9 vs 17.4 months with Tucatinib arm compared with Placebo arm; about 4.5 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 34 percent lower chance of the event at any given time (hazard ratio 0.66, likely range 0.5 to 0.88).
- 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: HER2+ metastatic breast cancer after trastuzumab, pertuzumab, and T-DM1, including active brain metastases: tucatinib + trastuzumab + capecitabine vs placebo + trastuzumab + capecitabine. 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.
612 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | Tucatinib arm | 320 | 7.8 months | 0.54 (0.42–0.71) | <0.001 | link |
| Placebo arm | 160 | 5.6 months | ||||
| Overall survival | Tucatinib arm | — | 21.9 months | 0.66 (0.5–0.88) | 0.005 | — |
| Placebo arm | — | 17.4 months |
Pages like this
not linked directly; found by shared links- TrialDESTINY-Breast12
Shares Systemic-first management of HER2-positive brain metastases, HER2-positive brain metastases, The brain: barrier and sanctuary, HER2-positive breast cancer.
- IdeaUse the brain's own transport door to carry antibody drugs across
Shares HER2-positive brain metastases, Tucatinib, The brain: barrier and sanctuary, HER2.
- TrialHER2CLIMB-05
Shares Tucatinib, Trastuzumab, HER2-positive breast cancer.
- IdeaDeliver CAR-T cells straight into the fluid around the brain
Shares HER2-positive brain metastases, The brain: barrier and sanctuary, HER2, HER2-positive breast cancer.
- TrialMOUNTAINEER & MOUNTAINEER-03
Shares Tucatinib, Trastuzumab, HER2.
- TrialALINA
Shares Stop excluding brain metastases from cancer trials, Prevention trials aimed only at brain metastasis.
- ProductNeratinib
Shares HER2-positive brain metastases, HER2, HER2-positive breast cancer.
- IdeaBrain metastases included by default in every solid-tumour trial
Shares Tucatinib, The brain: barrier and sanctuary, HER2-positive breast cancer.