OnCo
trialsTrialPositive

HER2CLIMB-05

In HER2CLIMB-05, adding the brain-penetrant pill tucatinib to maintenance antibodies after first-line chemotherapy delayed progression by more than eight months.

SABCS 2025: PFS 24.9 vs 16.3 months (HR 0.64, P<0.0001), consistent across brain-metastasis and hormone-receptor subgroups. Offers a chemotherapy-free maintenance intensification; its place versus first-line T-DXd + pertuzumab (DESTINY-Breast09) is unsettled.

Setting
First-line HER2+ metastatic breast cancer after induction with taxane + trastuzumab + pertuzumab: maintenance tucatinib + HP vs placebo + HP
Phase
Phase 3
Sponsor
Pfizer
Registry
Headline result
PFS 24.9 vs 16.3 months, HR 0.64.
Reported
2025
Enrolled
654
Replication
Consistent with HER2CLIMB; OS pending.

Outcomes

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In plain words
What these results mean for people, not percentages
654 people took part
Progression-free survivalprimarysurrogate endpoint
  • Median 24.9 vs 16.3 months with Tucatinib + trastuzumab + pertuzumab compared with Placebo + trastuzumab + pertuzumab; about 8.6 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 36 percent lower chance of the event at any given time (hazard ratio 0.641).
  • The p-value (<0.0001) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
  • 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: First-line HER2+ metastatic breast cancer after induction with taxane + trastuzumab + pertuzumab: maintenance tucatinib + HP vs placebo + HP. 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.

654 participants enrolled.

Progression-free survivalprimary
HR 0.641 · p <0.0001
Tucatinib + trastuzumab + pertuzumab
24.9 mo
Placebo + trastuzumab + pertuzumab
16.3 mo
Source
EndpointArmnValueHR (95% CI)pSource
Progression-free survivalprimaryTucatinib + trastuzumab + pertuzumab24.9 months0.641<0.0001link
Placebo + trastuzumab + pertuzumab16.3 months
Replication
Consistent with HER2CLIMB; OS pending.

Connected

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