Sacituzumab Govitecan in Pretreated HR+/HER2- Breast Cancer: TROPiCS-02 Trial
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On August 26, 2022, Hope S. Rugo and colleagues from the UCSF Helen Diller Family Comprehensive Cancer Center published the primary results of the TROPiCS-02 Phase 3 clinical trial in the Journal of Clinical Oncology. The study investigated the efficacy and safety of Sacituzumab govitecan (Trodelvy) in patients with hormone receptor-positive (HR+) and HER2-negative metastatic breast cancer who had progressed after endocrine therapy and CDK4/6 inhibitors.
Study Design: TROPiCS-02 Trial
This international, multicenter, randomized trial enrolled 543 patients with heavily pretreated HR+/HER2- metastatic breast cancer (median of 3 prior therapies). Participants were randomized to receive:
- Sacituzumab govitecan Group (N=272): 10 mg/kg on days 1 and 8 of a 21-day cycle.
- Chemotherapy Group (N=271): Physician's choice of chemotherapy (Eribulin, Capecitabine, Gemcitabine, or Vinorelbine).
The primary endpoint was progression-free survival (PFS).
Key Results
The trial achieved its primary objective, demonstrating a statistically significant improvement in PFS:
- Median PFS: 5.5 months for the Sacituzumab govitecan group vs. 4.0 months for the chemotherapy group (Hazard Ratio [HR] = 0.66).
- PFS Rates:
- 6-Month PFS: 46% (Sacituzumab govitecan) vs. 30% (Chemotherapy).
- 12-Month PFS: 21% (Sacituzumab govitecan) vs. 7% (Chemotherapy).
- Overall Survival (OS): An interim analysis showed a positive trend favoring Sacituzumab govitecan, which was later confirmed as statistically significant in subsequent updates.
Safety Profile
The incidence of Grade 3 or higher adverse events was 74% in the Sacituzumab govitecan group compared to 60% in the chemotherapy group. The most common Grade 3+ toxicities for Sacituzumab govitecan were neutropenia (51% vs. 38%) and diarrhea (9% vs. 1%).
Conclusion
The TROPiCS-02 results establish Sacituzumab govitecan as an important new treatment option for patients with pretreated HR+/HER2- metastatic breast cancer who have limited choices after failing CDK4/6 inhibitors and multiple lines of endocrine therapy.
Source: Journal of Clinical Oncology - TROPiCS-02 Results
#BreastCancer #HRPositive #SacituzumabGovitecan #Trodelvy #TROPiCS02 #CancerResearch #ADC
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