Trial reportClinical pharmacology and therapeutics2025
Exposure-Response Analyses of Sacituzumab Govitecan Efficacy and Safety in Patients With Metastatic Triple-Negative Breast Cancer.
Trial report in Clinical pharmacology and therapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The efficacy and safety of sacituzumab govitecan in the treatment of breast cancer: a systemic review and meta-analysis of emerging clinical data.Frontiers in immunology · 2025Pooled it
- Sacituzumab Govitecan Population Pharmacokinetics: Updated Analyses Using HR+/HER2- Metastatic Breast Cancer Data From the Phase 3 TROPiCS-02 Trial.Clinical and translational science · 2025Trial
- Exposure-Response Analyses of Sacituzumab Govitecan Efficacy and Safety in Patients With Metastatic Triple-Negative Breast Cancer.Clinical pharmacology and therapeutics · 2025Trial
- Primary G-CSF prophylaxis in sacituzumab govitecan-treated mTNBC: real-world evidence from a multinational CEBCC-102 cohort.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Observational
- Personalized medicine, scientific revolution or self-serving illusion: viewpoint from EORTC-PAMM Group.ESMO open · 2026Review
- Exposure-Response Relationships of Antibody Drug Conjugates in Solid Tumours.Clinical pharmacokinetics · 2026Review
- Effectiveness of sacituzumab govitecan in metastatic triple-negative breast cancer: a real-world retrospective cohort study from Central Europe.The oncologist · 2026Article
- Optimal Dosage Justification for Datopotamab Deruxtecan in HR-Positive/HER2-Negative Breast Cancer Through Model-Informed Drug Development Approaches.Clinical and translational science · 2026Article
- Sacituzumab Govitecan initial dose reduction in polish patients with metastatic triple-negative breast cancer: impact on efficacy and safety.Cancer chemotherapy and pharmacology · 2025Article
- Delphi consensus on the management of adverse events in patients with metastatic triple-negative breast cancer treated with sacituzumab govitecan.The oncologist · 2025Article
- Article
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Sacituzumab govitecan (SG), a Trop-2-directed antibody-drug conjugate, is approved for patients with metastatic triple-negative breast cancer (mTNBC) who received ≥2 prior systemic therapies (≥1 in metastatic setting). Exposure-response (E-R) relationships between SG exposure and efficacy and safety outcomes were characterized in 277 patients with mTNBC using data from the phase I/II IMMU-132-01 and phase III ASCENT (IMMU-132-05) studies. Evaluated endpoints included complete response (CR), objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety endpoints (individual first worst grade of select adverse events (AEs)). E-R analyses were also conducted for time to first dose reduction or delay. Patients received SG at 8 or 10 mg/kg intravenously on days 1 and 8 of a 21-day cycle. Average SG-related serum exposure over the treatment duration (until the event) was consistently the most significant exposure metric correlated with efficacy and safety endpoints. Higher average concentration over the treatment duration for SG (CAVG
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Registered trials
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