HER2 Negative Breast Cancer / SKB264 Monotherapy or Combination Therapy / Recurrence · Observational Study

Real-world Study of SKB264 Monotherapy or Combination Therapy in Recurrent or Metastatic HER2-negative Breast Cancer

ClinicalTrials.gov · August 18, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry record for an active, multi-center observational study of SKB264 (sacituzumab tirumotecan) in HER2-negative breast cancer, divided into TNBC and HR+/HER2− cohorts. No results are yet posted; the primary outcome is time to next treatment assessed to 24 weeks. Readers should await completion and results publication before drawing clinical conclusions.

What was studied

Observational. HER2-negative Breast Cancer, Recurrence, Metastasis; age from 18 Years. Intervention: TNBC Cohort; HR+/HER2- BC Cohort. n = 500. 19 sites: China.

Key findings

Safety

No efficacy, safety, or outcome data are reported in this registry record; study is actively recruiting. Cohort-specific efficacy and safety results are not yet available.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a registry record for an ongoing observational study with no results posted; recruitment is active and no efficacy or safety data are yet reported.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measure: Time to next treatment (TTNT) of SKB264 monotherapy or combination therapy in patients with unresectable locally advanced, recurrent or metastatic HER2-negative breast cancer (assessed at Time from initiation of SKB264 monotherapy or combination therapy to start of n…)

DesignObservational

PopulationHER2-negative Breast Cancer, Recurrence, Metastasis; age from 18 Years

Sample size500

InterventionTNBC Cohort; HR+/HER2- BC Cohort

Setting19 sites: China

Reported figures

Quoted from the source exactly as published.

Planned enrollment500

Primary outcome measureTime to next treatment (TTNT) of SKB264 monotherapy or combination therapy, assessed up to 24 weeks

Study cohortsTriple-negative breast cancer (TNBC) and hormone receptor-positive/HER2-negative (HR+/HER2−)

Caveats

No efficacy, safety, or outcome data are reported in this registry record; study is actively recruiting.
Observational design precludes causal inference and is susceptible to selection bias and confounding.
Primary outcome (TTNT) is a surrogate; hard clinical outcomes (overall survival, response rate) are not listed as primary measures.
Cohort-specific efficacy and safety results are not yet available.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Multi-center observational design; lacks randomization and blinding inherent to observational studies.

Directness

strong

Real-world setting directly addresses clinical practice; outcomes (TTNT) relevant to treatment sequencing.

Consistency

insufficient

No results reported; consistency cannot be assessed against other trials or benchmarks.

Risk of bias

insufficient

Study is recruiting; no methods detail on data collection, confounding adjustment, or loss to follow-up.

Sample adequacy

moderate

Planned enrollment 500 participants across two cohorts; adequate for descriptive real-world analysis.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06993506). This is a study registration, not published results. Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 500 participants (ESTIMATED). Conditions: HER2-negative Breast Cancer, Recurrence, Metastasis. Interventions: DRUG: SKB264 Monotherapy or Combination Therapy. Primary outcome measures: Time to next treatment (TTNT) of SKB264 monotherapy or combination therapy in patients with unresectable locally advanced, recurrent or metastatic HER2-negative breast cancer , Time from initiation of SKB264 monotherapy or combination therapy to start of next treatment, assessed up to 24 weeks.. Brief summary: This study is a multi-center observational real-world study, with a total of 500 patients planned to be enrolled. This study is divided into two cohorts: the triple-negative breast cancer (TNBC) cohort and the hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer (HR+/ HER2-BC) cohort. The aim of this study is to assess the efficacy and safety of Sacituzumab Tirumotecan (SKB264) monotherapy or combination therapy in patients with unresectable locally advanced, recurrent or metastatic HER2-negative breast cancer in the real-world setting.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

HER2 Negative Breast CancerSKB264 Monotherapy or Combination TherapyCancer Institute and Hospital, Chinese Academy of Medical SciencesRecurrenceNCT06993506Metastasis