HER2CLIMB-02
Adding tucatinib to Kadcyla helped a little, mostly in patients with brain metastases, but did not extend survival.
PFS 9.5 vs 7.4 months (HR 0.76); brain metastases subgroup 7.8 vs 5.7 months. OS not improved. Superseded by T-DXd second line and HER2CLIMB-05.
Setting
HER2+ metastatic breast cancer after trastuzumab and taxane: tucatinib + T-DM1 vs placebo + T-DM1
Phase
Phase 3
Sponsor
Seagen (Pfizer)
Registry
Headline result
PFS 9.5 vs 7.4 months, HR 0.76; OS no benefit.
Reported
2023
Enrolled
463
Replication
Consistent with HER2CLIMB's CNS signal.
In plain words
What these results mean for people, not percentages
Progression-free survivalprimarysurrogate endpoint
- Median 9.5 vs 7.4 months with Tucatinib + T-DM1 compared with Placebo + T-DM1; about 2.1 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 24 percent lower chance of the event at any given time (hazard ratio 0.76, likely range 0.61 to 0.95).
- 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.
- These results apply to the people the trial enrolled: HER2+ metastatic breast cancer after trastuzumab and taxane: tucatinib + T-DM1 vs placebo + T-DM1. 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.
463 participants enrolled.
Progression-free survivalprimary
HR 0.76 (0.61–0.95)
Tucatinib + T-DM1
9.5 mo
Placebo + T-DM1
7.4 mo
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | Tucatinib + T-DM1 | — | 9.5 months | 0.76 (0.61–0.95) | — | link |
| Placebo + T-DM1 | — | 7.4 months |
Replication
Consistent with HER2CLIMB's CNS signal.Pages like this
not linked directly; found by shared links- TrialHER2CLIMB-05
Shares Tucatinib, HER2-positive breast cancer.
- PairingTucatinib + trastuzumab + capecitabine for brain metastases
Shares Tucatinib, HER2-positive breast cancer.
- TrialDESTINY-Breast05
- PersonGunter von Minckwitz
- PersonNancy U. Lin
Shares Tucatinib, HER2-positive breast cancer.
- InstitutionDuke Cancer Institute
- IdeaBrain metastases included by default in every solid-tumour trial
Shares Tucatinib, HER2-positive breast cancer.
- IdeaSystemic-first management of HER2-positive brain metastases
Shares Tucatinib, HER2-positive breast cancer.