Epidemiology and Treatment of HR+/HER2- Breast Cancer in England

NCT07498413 | Completed

• 1 other identifier: CLEE011AGB02
• Study Type: observational
• Target: 218,677
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Metastatic breast cancer; Early breast cancer; Hormone receptor positive; Human epidermal growth factor receptor 2 negative; Progression; Cyclin-dependent kinase 4/6 inhibitors

Outcome Measures

Primary Outcomes (18)

• Time Between Start of Endocrine Therapy (ET) and Disease Progression

  Disease progression events include: * Return of breast cancer after initial treatment (non-metastatic recurrence) * Return and spread of breast cancer to other body parts after initial treatment (metastatic recurrence) * Death * Any other non-breast invasive cancer

  Up to approximately 12 years and 7 months

• Time between Non-metastatic Recurrence and Disease Progression

  Disease progression events include: * Further non-metastatic recurrence * Metastatic recurrence * Death

  Up to approximately 12 years and 7 months

• Time Between Metastatic Recurrence and Death

  Up to approximately 12 years and 7 months

• Number of Patients With Disease Progression by Health State Transition

  Health states: * Start of ET to non-metastatic recurrence * Start of ET to metastatic recurrence * Start of ET to death * Start of ET to any other non-breast invasive cancer * Non-metastatic recurrence to further non-metastatic recurrence * Non-metastatic recurrence to metastatic recurrence * Non-metastatic recurrence to death * Further non-metastatic recurrence to death * Metastatic recurrence to death

  Up to approximately 12 years and 7 months

• Invasive Disease-Free Survival (iDFS)

  iDFS was defined as time between start of ET to the first of any of non-metastatic recurrence, metastatic recurrence, non-breast invasive cancer, or death from any cause.

  Up to approximately 12 years and 7 months

• Hazard Ratio for Disease Progression Between Health States

  Health states: * Start of ET to non-metastatic recurrence * Start of ET to metastatic recurrence * Start of ET to death * Non-metastatic recurrence to further non-metastatic recurrence * Non-metastatic recurrence to metastatic recurrence * Non-metastatic recurrence to death * Further non-metastatic recurrence to death * Metastatic recurrence to death

  Up to approximately 12 years and 7 months

• Number of Patients by Number of Lines of Systemic Anti-cancer Therapy (SACT) Received

  Up to approximately 12 years and 7 months

• Number of Patients who Received Radiotherapy

  Up to approximately 12 years and 7 months

• Time From BC diagnosis to Treatment Initiation by Line of Therapy (LOT)

  Up to approximately 12 years and 7 months

• Number of Patients by Treatment Received Within Each LOT Ranked by Frequency of Use

  Treatments were ranked by most common (rank 1) to least common (rank 3).

  Up to approximately 12 years and 7 months

• Duration of Treatment Received for Each LOT by Rank Order

  Treatments were ranked by most common (rank 1) to least common (rank 3).

  Up to approximately 12 years and 7 months

• Number of Patients by Treatment Classes per LOT

  Up to approximately 12 years and 7 months

• Percentage of Patients by First SACT Used During Year of Diagnosis by Geographical Region

  Up to approximately 1 year

• Number of Patients Diagnosed With Early BC and Metastatic BC by Year of Diagnosis

  3 years

• Number of Patients Diagnosed with Early BC and Metastatic BC by Geographical Region

  3 years

• Number of Metastatic BC Patients by First-line Chemotherapy and Age Group

  Treatments were categorized as anthracycline with taxane, anthracycline without taxane, taxane without anthracycline, CDK4/6i, and other.

  Up to approximately 7 years and 10 months

• Number of Metastatic BC Patients by First-line Chemotherapy and Ethnicity

  Treatments were categorized as anthracycline with taxane, anthracycline without taxane, taxane without anthracycline, CDK4/6i, and other.

  Up to approximately 7 years and 10 months

• Number of Metastatic BC Patients by First-line Chemotherapy and Deprivation Quintile

  Deprivation quintiles ranged from 1 (least deprived) to 5 (most deprived). Treatments were categorized as anthracycline with taxane, anthracycline without taxane, taxane without anthracycline, CDK4/6i, and other.

  Up to approximately 7 years and 10 months

Secondary Outcomes (30)

• Number of Patients by Demographic Category

  Baseline

• Number of Patients by Clinical Characteristic Category

  Baseline

• Time From First Early BC Diagnosis to Metastatic BC Diagnosis

  Up to approximately 10 years and 7 months

• Number of Early BC Patients who Discontinued Treatment Within 6 Months of Treatment Initiation

  6 months

• Number of Early BC Patients by Reason for Discontinuing Treatment Within 6 Months of Treatment Initiation

  6 months

Study Arms (3)

HR+/HER2- Early BC Cohort

Adults with a diagnosis of HR+/HER2- early BC between 01 April 2012 and 31 December 2022.

HR+/HER2- Metastatic BC Cohort

Adults with a diagnosis of HR+/HER2- de novo or progressed metastatic BC between 01 April 2012 and 31 December 2022.

NATALEE Trial-aligned Sub-cohort

Patients from the HR+/HER2- Early BC Cohort consisting of patients with stage II BC and stage III BC. This sub-group closely resembled the NATALEE trial population.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults captured in the cancer registry with a diagnosis of HR+/HER2- early BC or metastatic BC between 01 April 2012 and 31 December 2022.

You may qualify if:

• 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.
• 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.
• No evidence of metastatic disease (defined above) before or up to 100 days after the first BC diagnosis date.
• 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.

You may not qualify if:

• Patient's sex unknown.
• Patient with ductal carcinoma in situ (DCIS), or lobular carcinoma in situ (LCIS).
• 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.
• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

London, W12 7FQ, United Kingdom

Location

Related Links

• Link to study results

MeSH Terms

Conditions

Breast Neoplasms; Disease Progression

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: June 8, 2023
• Primary Completion: July 18, 2025
• Study Completion: July 18, 2025
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)