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NCT06125314
HER2 TREAT Study: Retrospective Study to Estimate the Prevalence of HER2-low in Unresectable and/or Metastatic Breast Cancer Patients Who Progress on Anti-Cancer Therapy Identified as HER2-Negative From Patient Medical Records in The Gulf Cooperation Council
trial in Breast Neoplasms in 517 participants. Completed in 30 September 2024.
30 September 2024
Quick facts
| Lead sponsor | AstraZeneca |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 517 |
| Start date | 5 March 2024 |
| Primary completion | 30 September 2024 |
| Estimated completion | 30 September 2024 |
| Sites | 7 locations across Qatar, Saudi Arabia, Kuwait, United Arab Emirates |
Conditions studied
- Breast Neoplasms — all drugs for Breast Neoplasms →
- Breast Cancer — all drugs for Breast Cancer →
- Breast Carcinoma — all drugs for Breast Carcinoma →
- Genes — all drugs for Genes →
Sponsor
AstraZeneca — full company profile →
Who can join
Eligibility, female only, with Breast Neoplasms or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
HER2-low Breast cancer (BC) has emerged as a new subtype of BC with distinct clinical, pathological, and prognostic features. Little is known about the prevalence of the HER2-low subtype in HER2-negative patients, and previous reports showed variations in the criteria used to define the HER2-low subtype. Besides, data on the clinical features and prognosis of HER2-low patients are limited, and it is still unclear whether HER2-low BC has a prognostic value. Identifying the prevalence and clinical features of HER2-low BC can help establish a more accurate and reproducible definition of HER2-low BC. In the Gulf Cooperation Council (GCC) region, BC is the most common malignancy in women and still poses a significant burden on healthcare resource utilization, moreover, there is only one record for reimbursed HER2 IHC status, categorized as HER2-positive and HER2-negative. It is important to understand the prevalence, clinical features, and outcomes of HER2-low in BC patients from the GCC In this retrospective, non-interventional, multicenter study, the aim to describe the prevalence of HER2-low BC among the current HER2-negative BC population using rescored HER2 IHC samples. The local treatment patterns and the outcomes will be analyzed using the information abstracted from the corresponding medical chart review. The study will cover the GCC region countries (United Arab Emirates \[UAE\], Saudi Arabia, Qatar, Kuwait, and Oman)
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 NCT06125314
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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 NCT06125314 (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: 23 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/NCT06125314.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing