NCT07498413Completed
Epidemiology and Treatment of HR+/HER2- Breast Cancer in England
Source: ClinicalTrials.gov · Last updated 1 Apr 2026
Brief summary (registry, in English)
The aim of this study was to describe the epidemiology, treatment pathway, treatment access, wastage of cyclin-dependent kinase 4/6 inhibitors (CDK4/6i), and health care resource use among adults with hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer (BC) in England, including their treatment pathway leading to progression to metastatic BC for those who were initially diagnosed with early BC. This was a retrospective cohort study using linked registry and administrative data.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 218677 (actual)
- First submitted
- 23 Mar 2026
- Start date
- 8 Jun 2023
- Primary completion date
- 18 Jul 2025
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07498413
What you commit to
- Study type: Observational
- Participants enrolled: 218677
- From 8 Jun 2023 to the primary completion date, 18 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient with any indication of co-positive disease before or within 6 months after diagnosis (i.e., HR+ and HER2+) including:
- treated with trastuzumab
- treated with tyrosine kinase inhibitors (TKIs)
- Any registered BC tumor or evidence of metastatic cancer prior to index date.
Other illness
- Patient with a diagnosis of Second Edition of the International Classification of Diseases for Oncology (ICD-0-O2) code 0, 1, or 2 denoting non-malignant disease.
Other
- Patient's sex unknown.
- Patient with ductal carcinoma in situ (DCIS), or lobular carcinoma in situ (LCIS).
Who the study is looking for
- Patient with a registered diagnosis of International Classification of Diseases,10th Revision (ICD-10) code C50: malignant neoplasm of the breast, between 01 April 2012 and 31 December 2022.
- Patient ≥18 years of age at diagnosis.
- Patient with estrogen receptor-positive (ER+) or progesterone receptor-positive (PR+), i.e., hormone receptor positive (HR+) breast cancer
- Patient with human epidermal growth factor receptor 2 negative (HER2-) breast cancer.
- Additional inclusion criteria for patients with metastatic BC were defined as:
- Tumor stage IV at diagnosis or on subsequent treatment or
- Tumor Node Metastases (TNM) staging indicative of M1 at diagnosis or on subsequent treatment or
- Record with ICD-10 codes indicating secondary malignant neoplasm C77\* (excluding C771 and C773), C78\*, or C79\* or
- Initiation of treatment specified for metastatic BC, defined as ribociclib or palbociclib from 01 January 2017 to the end of the study period or abemaciclib from 01 January 2017 to 31 May 2022 or
- Record of treatment for distant/metastatic recurrence.
- An additional inclusion criterion for patients with early BC was:
- No evidence of metastatic disease (defined above) before or up to 100 days after the first BC diagnosis date.
- Additional inclusion criteria for patients in the NATALEE Trial-aligned sub-cohort:
- Patient with stage IIa BC at diagnosis (i.e., T0-1 N1 or T2 N0 with Grade 3 tumor), or
- Stage IIb BC at diagnosis (i.e., T2 N1, T3 N0), or
- Stage III BC at diagnosis.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novartis Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.