Advanced breast cancer (TNBC, or HR+ after endocrine therapy and chemotherapy)
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Sacituzumab govitecan | 10 mg/kg | IV (first dose over 3 hours, then 1 to 2 hours) | Days 1 and 8 |
As in ASCENT; dose source:.
Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer
Bardia A, Hurvitz SA, Tolaney SM, et al. N Engl J Med. 2021. 384:1529-1541
- Study type
- Clinical trial
- Study name
- ASCENT
- Phase
- Phase 3
- Design
- Randomised, open-label, multicentre trial; 1:1 randomisation
- Sample size
- 529 patients randomised; primary analysis population 468 patients without brain metastases (235 sacituzumab govitecan, 233 chemotherapy)
- Source
- N Engl J Med · 2021
- Trial registration
- NCT02574455
In plain words
Triple-negative breast cancer has no hormone receptors and no HER2, and after several lines of chemotherapy the treatment options are limited. Sacituzumab govitecan (Trodelvy) is an antibody that carries a strong chemotherapy drug to cells that carry the Trop-2 protein. In ASCENT, compared with usual chemotherapy, this medicine extended the time the disease was kept under control from about 2 months to about 6 months and the median survival from about 7 months to about 12 months. A low white blood cell count and diarrhoea are the main side effects, and the care team usually prescribes supportive medicines to prevent them.
Key results
5.6 vs 1.7 months
Median progression-free survival
HR 0.41 (95% CI, 0.32 to 0.52); P<0.001
12.1 vs 6.7 months
Median overall survival
HR 0.48 (95% CI, 0.38 to 0.59); P<0.001
35% vs 5%
Objective response
Dose and schedule cards
Sacituzumab govitecan
Advanced breast cancer (TNBC, or HR+ after endocrine therapy and chemotherapy)Cycle length: Every 21 daysOn the page “Sacituzumab govitecan (Trodelvy)”
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Treatment arms and regimens
1Sacituzumab govitecan
Sacituzumab govitecan (Trodelvy) 10 mg/kg IV infusion on days 1 and 8 of each 21-day cycle, until disease progression or unacceptable toxicity.
2Single-agent chemotherapy of physician's choice (control arm)
One of these drugs, chosen before randomisation: eribulin 1.4 mg/m² (North America) or 1.23 mg/m² (Europe) IV on days 1 and 8 every 21 days; capecitabine 1000 to 1250 mg/m² orally twice daily on days 1 to 14 every 21 days; gemcitabine 800 to 1200 mg/m² IV on days 1, 8 and 15 every 28 days; or vinorelbine 25 mg/m² IV weekly.
Source of the regimen details: FDA label for Trodelvy (TRODELVY, version 2026-06, sections 2 and 14); ClinicalTrials.gov NCT02574455 (doses of the control-arm drugs).
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Patients with relapsed or refractory metastatic or unresectable locally advanced triple-negative breast cancer who had received at least two prior lines of chemotherapy (one could be neoadjuvant/adjuvant, provided progression occurred within 12 months) and a prior taxane. Up to 15% of patients with stable brain metastases were allowed. Median age was 54 years.
Endpoints
Primary endpoint: progression-free survival (by blinded independent central review) in patients without brain metastases.
Secondary endpoints: overall survival, objective response and safety.
Safety and side effects
Treatment-related grade 3 or higher adverse events (sacituzumab govitecan versus chemotherapy): neutropenia 51% versus 33%, leucopenia 10% versus 5%, diarrhoea 10% versus less than 1%, anaemia 8% versus 5% and febrile neutropenia 6% versus 2%. Three deaths due to adverse events occurred in each group, none considered related to sacituzumab govitecan.
Clinical significance and place in guidelines
On the basis of this study, the FDA granted full approval in April 2021 to sacituzumab govitecan for patients with metastatic or unresectable locally advanced triple-negative breast cancer who have received two or more prior systemic therapies (at least one for metastatic disease); this indication remains in the current label, and sacituzumab govitecan became a standard second-line and later treatment in this disease.
Limitations
The trial was open-label. The control arm was single-agent chemotherapy with limited efficacy in this setting. The primary analysis excluded patients with brain metastases. Haematological and gastrointestinal toxicity is considerable and G-CSF support may be needed.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.