Breast Neoplasms / Neoplasm Metastasis / Breast Cancer · Observational Study

PROVIDENCE - Prospective Non-interventional Study (NIS) to Examine Patient-reported Outcomes and Real-world Clinical Data in Patients With HER2-positive, HER2-low or HER2-ultralow Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan

ClinicalTrials.gov · August 12, 2026

Preliminary Why this matters to you Expert discussion

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

AI Summary

This is an active, prospective observational registry of trastuzumab deruxtecan in HER2-positive, HER2-low, and HER2-ultralow unresectable or metastatic breast cancer in routine German practice. No outcomes are reported in this registry record; it documents study design and enrollment target only. Results will be exploratory real-world evidence once accrual and follow-up are complete.

What was studied

Observational. Breast Neoplasms, Breast Cancer, Neoplasm Metastasis; age from 18 Years; to 130 Years. Intervention: Cohort 1; Cohort 2. n = 800. 109 sites: Germany.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

This record documents a real-world registry study in development; no clinical guidance can be drawn until results are available. Once mature, it will provide observational safety and efficacy data on T-DXd outside clinical trial conditions.

Plain-language summary

This is a prospective registry study under active recruitment with no results yet posted; it will generate real-world observational data on a marketed drug but cannot yet support clinical inference.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measure: Real-world Time To Next Treatment (rwTTNT1) (assessed at From first dose of T-DXd until initiation of subsequent therapy or death of any…)

DesignObservational

PopulationBreast Neoplasms, Breast Cancer, Neoplasm Metastasis; age from 18 Years; to 130 Years

Sample size800

InterventionCohort 1; Cohort 2

Setting109 sites: Germany

Reported figures

Quoted from the source exactly as published.

Estimated enrollment800

Primary outcome measureReal-world Time To Next Treatment (rwTTNT1) from first dose of T-DXd until initiation of subsequent therapy or death, assessed up to 60 months

Study phaseObservational

Recruitment statusRECRUITING

Clinical bottom line

Caveats

This is a registry record with no results posted; no outcomes, effect sizes, or clinical inferences are available.
Observational design without a comparator; cannot assess relative efficacy or establish causality.
Study is still recruiting; final sample size, follow-up duration, and outcomes are not yet reported.
No publication or peer-reviewed results are referenced in this registry record.

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

Prospective observational design; no comparator or randomisation.

Directness

moderate

Real-world data in clinical practice; primary outcome is time-to-next-treatment.

Consistency

insufficient

Registry record; no results yet reported for consistency assessment.

Risk of bias

limited

Non-interventional design; no blinding. Observational data subject to confounding.

Sample adequacy

moderate

Estimated enrollment 800 participants; adequate for real-world registry study.

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 (NCT05573893). This is a study registration, not published results. Lead sponsor: AstraZeneca. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 800 participants (ESTIMATED). Conditions: Breast Neoplasms, Breast Cancer, Neoplasm Metastasis. Primary outcome measures: Real-world Time To Next Treatment (rwTTNT1) , From first dose of T-DXd until initiation of subsequent therapy or death of any cause, whichever came first, assessed up to 60 months. Brief summary: This is a prospective non-interventional, multicenter study observing patient reported outcomes as well as real-world efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients with documented Human epidermal growth factor receptor 2 (HER2)-positive, HER2-low or HER2-ultralow unresectable or metastatic breast cancer (BC) receiving T-DXd in line with the applicable summary of product characteristics (SmPC) within routine clinical practice in Germany. In addition, patients will be informed about use of digital healthcare application (DiGA).

Follow from this

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

NCT05573893Breast NeoplasmsNeoplasm MetastasisBreast CancerAstraZeneca