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NCT06131424: iRetroBC
NIS Study Determining Prevalence of HER2-low in Metastatic Breast Cancer Patients
trial in HER2-negative in 1,151 participants. Completed in 19 May 2025.
19 May 2025
Quick facts
| Lead sponsor | AstraZeneca |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,151 |
| Start date | 23 April 2024 |
| Primary completion | 19 May 2025 |
| Estimated completion | 19 May 2025 |
| Sites | 31 locations across Hong Kong, Panama, Dominican Republic, Malaysia, Indonesia, Vietnam, Mexico, Philippines |
Conditions studied
- HER2-negative — all drugs for HER2-negative →
Sponsor
AstraZeneca — full company profile →
Who can join
18 and older, any sex, with HER2-negative. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This noninterventional, multicenter,retrospective study has been proposed to estimate the prevalence, clinicopathological characteristics,treatment patterns and clinical outcomes of human epidermal growth factor receptor 2 -(HER2)low locally-advanced or metastatic breast cancer(mBC) by accurate rescoring of archived IHC-stained formalin-fixed paraffin-embedded (FFPE) slides for HER2 in patients previously identified as HER2-negative from emerging markets of international regions (non-US and non-European region) with largely unknown prevalence estimates of HER2 low mBCs. Patients with a confirmed diagnosis of HER2-negative, locally-advanced or mBC regardless of Hormone receptor (HR)status between 01 January 2019 and 31 December 2022 who progressed on any systematic anticancer therapy (eg, ET, chemotherapy, CDK4/6 inhibitor, targeted therapies other than anti-HER2, or immunotherapy) in advanced disease with availability of atleast 12 months of follow-up data (from the index date) in the medical records at the participating site, unless patient died within the first 12 months of diagnosis of locally-advanced or mBC will be enrolled in the study. The HR positive patients will be considered eligible for the study if they have received ET as adjuvant therapy in the early BC setting and progressed within 24 months. This scenario will be considered as progression on systematic treatment in the advanced or metastatic setting.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06131424
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for HER2-negative
Currently open trials in the same condition.
- NCT06769425 — HS-10502 Combination Treatment in Patients With Advanced Solid Tumors · Phase 1 · recruiting
Other AstraZeneca trials
Trials by the same sponsor.
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- NCT07431775 — Saphnelo Use in Females of Child-bearing Potential · not yet recruiting
- NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis · NA · not yet recruiting
- NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec · Phase 4 · not yet recruiting
- NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06131424 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
- Last refreshed: 18 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06131424.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing