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

Plain English Summary

Epidemiology and Treatment of HR+/HER2- Breast Cancer in England is a Not Applicable clinical trial sponsored by Novartis Pharmaceuticals studying Breast Cancer. This study looks at how hormone-driven, HER2-negative breast cancer is treated in England. It is for adults diagnosed with this specific type of breast cancer. Participation involves reviewing existing health records; no new treatments are given. This is an observational study, meaning it observes current practices rather than testing new interventions. The trial aims to enroll 218677 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 or older diagnosed with hormone receptor-positive, HER2-negative breast cancer in England between April 2012 and December 2022 can be included. Patients with early-stage or metastatic breast cancer meeting specific criteria are eligible. Individuals with unknown sex, certain non-malignant breast conditions, or prior co-positive (HR+ and HER2+) disease are excluded. This trial is studying Breast Cancer, so participants generally need a confirmed diagnosis.

What They're Measuring

The study measures how long patients live without their cancer worsening or returning, and how long they live after their cancer has spread, to understand treatment effectiveness. The specific primary outcome measures are: Time Between Start of Endocrine Therapy (ET) and Disease Progression (Up to approximately 12 years and 7 months); Time between Non-metastatic Recurrence and Disease Progression (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 (Up to approximately 12 years and 7 months); Invasive Disease-Free Survival (iDFS) (Up to approximately 12 years and 7 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it aims to understand how a common type of breast cancer is treated in England, identifying potential gaps in care and access to specific medications. This research targets Breast Cancer, where improved treatment options are needed.

Investor Insight

This observational study by Novartis provides insights into the real-world use and access of CDK4/6 inhibitors for HR+/HER2- breast cancer in England, informing market dynamics and treatment strategie The large enrollment target of 218677 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if your breast cancer is HR+/HER2- and how this study might relate to your treatment. Your participation is based on your existing medical records, so no direct actions are required from you. The study uses anonymized data, meaning your personal information is protected. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: OBSERVATIONAL
• Enrollment: 218,677 participants

Primary Outcomes

• Time Between Start of Endocrine Therapy (ET) and Disease Progression (Up to approximately 12 years and 7 months)
• Time between Non-metastatic Recurrence and Disease Progression (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 (Up to approximately 12 years and 7 months)
• Invasive Disease-Free Survival (iDFS) (Up to approximately 12 years and 7 months)

Secondary Outcomes

• 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)

Full Eligibility Criteria

Inclusion criteria:

* 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.

Exclusion criteria:

* 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.

Trial Locations

• Novartis, London, United Kingdom

Frequently Asked Questions

Related Conditions

• Breast Cancer
• Hormone Receptor Positive Breast Cancer
• HER2-Negative Breast Cancer
• Metastatic Breast Cancer
• Early Breast Cancer
• Endocrine Therapy
• Oncology
• Cancer Epidemiology
• Malignant Neoplasm of Breast
• Cyclin-Dependent Kinase 4/6 Inhibitors

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