# TROPiCS-02

Source: https://onco.cc/trials/tropics-02/  
OnCo record `tropics-02` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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

## Summary

TROPiCS-02, trial NCT03901339 sponsored by Gilead and reported in 2022, showed that the TROP2 antibody-drug conjugate sacituzumab govitecan extends survival in heavily pretreated HR-positive, HER2-negative metastatic breast cancer. It randomised 543 women who had received endocrine therapy, a CDK4/6 inhibitor and two to four chemotherapies to sacituzumab govitecan or chemotherapy, met its primary progression-free survival endpoint and showed an overall survival benefit of a few months, leading to approval in February 2023 and establishing antibody-drug conjugates in this disease after chemotherapy. OnCo links it to TROP2 as a target, sacituzumab govitecan and Hope S. Rugo. Whether TROP2 ADCs should move earlier, before chemotherapy, is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT03901339
- Phase: 3
- Setting: HR+/HER2- metastatic breast cancer after endocrine therapy, CDK4/6, and 2-4 chemotherapies: sacituzumab govitecan vs chemotherapy
- Sponsor: Gilead
- Enrolled: 543
- Result: OS 14.4 vs 11.2 months, HR 0.79.
- Outcomes: Progression-free survival: Sacituzumab govitecan 5.5 months vs Chemotherapy 4 months, HR 0.66; Overall survival: Sacituzumab govitecan 14.4 months vs Chemotherapy 11.2 months, HR 0.79
- Replication: TROPION-Breast01 (Dato-DXd) replicated the PFS effect of a TROP2 ADC in this population but not OS.

## Sources

- ClinicalTrials.gov NCT03901339: https://clinicaltrials.gov/study/NCT03901339

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [HR-positive metastatic breast cancer after CDK4/6 inhibitors](https://onco.cc/cancers/hr-positive-metastatic-post-cdk46/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/), [Topoisomerase-I inhibitors (and ADC payloads)](https://onco.cc/technologies/topoisomerase-inhibitors/)
- targets: [TROP2](https://onco.cc/targets/trop2/)
- drugs: [Sacituzumab govitecan](https://onco.cc/drugs/sacituzumab-govitecan/)
- companies: [Gilead Sciences (incl. Kite)](https://onco.cc/companies/gilead/)
- people: [Hope S. Rugo](https://onco.cc/people/hope-rugo/)
- key papers: [Overall survival with sacituzumab govitecan in hormone receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPiCS-02): a randomised, open-label, multicentre, phase 3 trial](https://onco.cc/key-papers/paper-tropics-02-lancet-2023/)

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