A new study suggests that Trodelvy (sacituzumab govitecan) may offer an important new treatment option for patients with advanced triple-negative breast cancer (TNBC) who are not eligible for immunotherapy. Results from the phase 3 ASCENT-03 clinical trial, presented at the 2025 ESMO Congress, showed that Trodelvy significantly delayed cancer progression compared with standard chemotherapy.
Key Findings from the ASCENT-03 Study
- Trodelvy reduced the risk of cancer progression or death by 38% compared with chemotherapy.
- Patients treated with Trodelvy had a median progression-free survival (PFS) of 9.7 months vs. 6.9 months with chemotherapy.
- Tumor shrinkage rates were similar, but the duration of response was much longer with Trodelvy (12.2 months vs 7.2 months).
- The treatment benefit was seen across different patient subgroups, including those with varying disease characteristics and ages.
According to experts, these data support Trodelvy as a potential new first-line treatment option for patients with metastatic TNBC unable to receive immune checkpoint inhibitors.
Understanding Side Effects and Safety
Side effects were generally consistent with what doctors would expect from advanced breast cancer treatments. The most common serious side effects with Trodelvy included:
- Low white blood cell counts (neutropenia) – 43%
- Diarrhea – 9%
- Low total white blood cell counts (leukopenia) – 7%
Only 4% of patients stopped Trodelvy due to side effects, compared with 12% who stopped chemotherapy. Doctors may use preventive medicines such as G-CSF (a white blood cell growth factor) to help manage potential complications like infection or neutropenia.
Why This Matters for Patients with TNBC
Metastatic triple-negative breast cancer remains one of the most difficult types of breast cancer to treat. Unlike other types, TNBC lacks hormone receptors and HER2 expression, which means fewer treatment options. Many patients cannot receive immunotherapy because their tumors do not express PD-L1.
About the ASCENT-03 Clinical Trial
- Conducted internationally as an open-label, phase 3 study.
- Enrolled patients with previously untreated, locally advanced, unresectable, or metastatic TNBC who could not receive immunotherapy.
- Participants were randomly assigned to receive either Trodelvy or standard chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine with carboplatin).
- Treatment continued until the cancer worsened or side effects became intolerable.
- The main goal (primary endpoint) was progression-free survival (PFS).
Although overall survival results are still being evaluated, early data show a clear improvement in disease control with Trodelvy.
Looking Ahead
Trodelvy is already approved to treat metastatic TNBC after prior therapies. These new findings suggest it may also benefit patients as an earlier-line treatment, offering improved outcomes and more time before cancer progresses. Ongoing research continues to explore its role across breast cancer subtypes and stages.
References:
Cortés JC, Bardia A, Punie K, et al. Primary results from ASCENT-03: A randomized phase III study of sacituzumab govitecan (SG) vs chemotherapy (chemo) in patients (pts) with previously untreated advanced triple-negative breast cancer (TNBC) who are unable to receive PD-(L)1 inhibitors (PD-[L]1i). Presented at: 2025 ESMO Annual Congress; October 17-21, 2025; Berlin Germany. Abstract LBA20.
Cortés J, Punie K, Barrios C, et al. Sacituzumab Govitecan in Untreated, Advanced Triple-Negative Breast Cancer. N Engl J Med. 2025. doi:10.1056/NEJMoa2511734
