OnCo
trialsTrialPositive

TROPiCS-02

The TROP2 ADC extended survival by about three months in heavily pretreated hormone-positive breast cancer.

PFS 5.5 vs 4.0 months (HR 0.66); OS 14.4 vs 11.2 months (HR 0.79). Approved February 2023. Established ADCs in HR+ disease after chemotherapy, later joined by Dato-DXd (TROPION-Breast01) and T-DXd in HER2-low (DESTINY-Breast04/06).

Setting
HR+/HER2- metastatic breast cancer after endocrine therapy, CDK4/6, and 2-4 chemotherapies: sacituzumab govitecan vs chemotherapy
Phase
Phase 3
Sponsor
Gilead
Registry
Headline result
OS 14.4 vs 11.2 months, HR 0.79.
Reported
2022
Enrolled
543
Replication
TROPION-Breast01 (Dato-DXd) replicated the PFS effect of a TROP2 ADC in this population but not OS.

Outcomes

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In plain words
What these results mean for people, not percentages
543 people took part
Progression-free survivalprimarysurrogate endpoint
  • Median 5.5 vs 4 months with Sacituzumab govitecan compared with Chemotherapy; about 1.5 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 0.53 to 0.83).
  • 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 survivalsurvival endpoint
  • Median 14.4 vs 11.2 months with Sacituzumab govitecan compared with Chemotherapy; about 3.2 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 21 percent lower chance of the event at any given time (hazard ratio 0.79, likely range 0.65 to 0.96).
  • 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: HR+/HER2- metastatic breast cancer after endocrine therapy, CDK4/6, and 2-4 chemotherapies: sacituzumab govitecan vs chemotherapy. 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.

543 participants enrolled.

Progression-free survivalprimary
HR 0.66 (0.53–0.83) · p = 0.0003
Sacituzumab govitecan
5.5 mo
Chemotherapy
4 mo
Source
Overall survival
HR 0.79 (0.65–0.96) · p = 0.02
Sacituzumab govitecan
14.4 mo
Chemotherapy
11.2 mo
EndpointArmnValueHR (95% CI)pSource
Progression-free survivalprimarySacituzumab govitecan2725.5 months0.66 (0.53–0.83)0.0003link
Chemotherapy2714 months
Overall survivalSacituzumab govitecan14.4 months0.79 (0.65–0.96)0.02
Chemotherapy11.2 months
Replication
TROPION-Breast01 (Dato-DXd) replicated the PFS effect of a TROP2 ADC in this population but not OS.

Connected

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