Disease × agent evidence record

Sacituzumab Govitecan for Breast Cancer: evidence, trials and status

Trials of Sacituzumab Govitecan in Breast Cancer are registered but none has completed, so there is no outcome evidence from those studies yet; the record is a signal of research interest.

8 registered trials 4 recruiting 15 publications Evidence tier A · Strong Score 73.0
Research Tracker › Pairs › Breast Cancer › Sacituzumab Govitecan
Research map, not treatment advice. This page aggregates registry and literature records. It does not evaluate efficacy, dosing or safety for any individual. Discuss any treatment decision with a qualified clinician.

Summary

Sacituzumab Govitecan has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Breast Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Breast Cancer. ClinicalTrials.gov lists 8 registered trials linking Sacituzumab Govitecan to Breast Cancer: 4 are currently recruiting; 2 are active or not yet recruiting; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT05840211). It plans or enrolled 654 participants. Registration activity spans 2023 to 2026. The literature layer holds 15 publications for this pair: 5 Cochrane reviews, 2 meta-analyses, 2 systematic reviews, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2025 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.

The RepurpOS disease-intelligence file for Breast Cancer ranks 1462 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous regression documented but rare (<0.5%); 5-year survival stage I: ~99%; stage IV: ~28% overall, improving with modern therapy.

Open in Repurposing ExplorerBreast Cancer hubBreast Cancer biomarkers & interventions

Evidence table

Evidence tierA · Strong
Evidence score73.0 (trials 23.0, literature 30.0, tier 15, approved bonus 5.0)
Registered trials8 total: 4 recruiting, 2 active / not yet recruiting, 0 completed, 2 other
Linked publications15 (5 Cochrane reviews, 5 clinical trial publications, 2 meta-analyses, 2 systematic reviews, 1 randomised controlled trial publication)
Agent typeDrug (Small molecule)
Development stage (any indication)Approved
Mechanism / classNot recorded
Data sourcesDGIdb
Linked via biomarker / targetBRCA1
How the evidence score is calculated
  • Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
  • Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
  • The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
  • Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
  • The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.

Registered clinical trials

NCT IDTitleStatusPhaseEnrolment
NCT05840211Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy
2023
active, not recruitingPhase 3654
NCT06102824Organoid-based Functional Precision Therapy for Advanced Breast Cancer
2024
recruitingPhase 2252
NCT05774886Implantable Microdevice for TNBC - Pilot Study
2023
withdrawnPhase 1—
NCT06612203Clinical Study to Evaluate Debio0123 + Sacituzumab Govitecan Combination in TNBC or HR+/HER2- Advanced Breast Cancer
2025
active, not recruitingPHASE1, PHASE276
NCT04320693Expanded Access for IMMU-132approved_for_marketingNot applicable—
NCT07046455Trop-2 Targeted PET Probes in Advanced TNBC
2025
recruitingNot applicable20
NCT07582887Impact of Genetic Variants on the Toxicity of Antibody-Drug Conjugates in Locally Advanced or Metastatic Breast Cancer: The Role of the UGT1A1 Gene as a Predictive Biomarker of Therapeutic Response
2025
recruitingNot applicable70
NCT06462092Sacituzumab Govitecan and Intrathecal Chemotherapy for Treating Leptomeningeal Metastases From Her2-negative Breast Cancer
2026
recruitingPHASE1, PHASE234

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Published literature

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Mechanism and notes

No mechanism of action is recorded for this pair in the source databases.

OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target BRCA1. The tier describes how well the drug-disease link is documented, not how well the drug works.

Frequently asked questions

Is Sacituzumab Govitecan approved for Breast Cancer?

Sacituzumab Govitecan has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Breast Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Breast Cancer. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.

Is Sacituzumab Govitecan in clinical trials for Breast Cancer?

ClinicalTrials.gov lists 8 registered trials linking Sacituzumab Govitecan to Breast Cancer: 4 are currently recruiting; 2 are active or not yet recruiting; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT05840211). It plans or enrolled 654 participants. Registration activity spans 2023 to 2026.

What does the evidence show for Sacituzumab Govitecan in Breast Cancer?

Trials of Sacituzumab Govitecan in Breast Cancer are registered but none has completed, so there is no outcome evidence from those studies yet; the record is a signal of research interest. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target BRCA1. The tier describes how well the drug-disease link is documented, not how well the drug works.

Cite this page

Open Source Medicine Foundation. Sacituzumab Govitecan for Breast Cancer: evidence, trials and status. OSMF Research Tracker. Updated 2026-07-05. https://research.opensourcemed.info/pairs/breast-cancer/sacituzumab-govitecan.html

Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.

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This is a research map, not treatment advice. Evidence tiers and scores summarise what has been studied, not whether a treatment works or is safe for you.