OnCo
trialsTrialPositive

CLEOPATRA

Adding a second HER2 antibody, pertuzumab, extended survival by 16 months, the largest gain ever seen in metastatic breast cancer at the time.

PFS 18.7 vs 12.4 months (HR 0.68); final OS 57.1 vs 40.8 months (HR 0.69); 8-year landmark OS 37% vs 23%. Defined first-line 'THP' until DESTINY-Breast09 (2025).

Setting
First-line HER2+ metastatic breast cancer: pertuzumab + trastuzumab + docetaxel vs placebo + trastuzumab + docetaxel
Phase
Phase 3
Sponsor
Roche / Genentech
Registry
Headline result
OS 57.1 vs 40.8 months, HR 0.69.
Reported
2011
Enrolled
808
Replication
Dual blockade benefit replicated in neoadjuvant (NeoSphere pCR) and adjuvant (APHINITY) settings.

Outcomes

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In plain words
What these results mean for people, not percentages
808 people took part
Progression-free survivalprimarysurrogate endpoint
  • Median 18.7 vs 12.4 months with Pertuzumab + trastuzumab + docetaxel compared with Placebo + trastuzumab + docetaxel; about 6.3 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 32 percent lower chance of the event at any given time (hazard ratio 0.68, likely range 0.58 to 0.8).
  • 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.
Overall survival (final)survival endpoint
  • Median 57.1 vs 40.8 months with Pertuzumab arm compared with Placebo arm; about 16.3 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 31 percent lower chance of the event at any given time (hazard ratio 0.69, likely range 0.58 to 0.82).
  • Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
Be careful
  • These results apply to the people the trial enrolled: First-line HER2+ metastatic breast cancer: pertuzumab + trastuzumab + docetaxel vs placebo + trastuzumab + docetaxel. 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.

808 participants enrolled.

Progression-free survivalprimary
HR 0.68 (0.58–0.8)
Pertuzumab + trastuzumab + docetaxel
18.7 mo
Placebo + trastuzumab + docetaxel
12.4 mo
Source
Overall survival (final)
HR 0.69 (0.58–0.82)
Pertuzumab arm
57.1 mo
Placebo arm
40.8 mo
Source
EndpointArmnValueHR (95% CI)pSource
Progression-free survivalprimaryPertuzumab + trastuzumab + docetaxel40218.7 months0.68 (0.58–0.8)link
Placebo + trastuzumab + docetaxel40612.4 months
Overall survival (final)Pertuzumab arm57.1 months0.69 (0.58–0.82)link
Placebo arm40.8 months
Replication
Dual blockade benefit replicated in neoadjuvant (NeoSphere pCR) and adjuvant (APHINITY) settings.

Connected

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