A Retrospective Study to Understand the Clinical Characteristics andthe Treatment for Breast CancerPatients
- Conditions
- Malignant neoplasm of breast of unspecified site,
- Registration Number
- CTRI/2023/07/055665
- Lead Sponsor
- Clinart MENA
- Brief Summary
The current observational study aims to obtain real-world data about the proportion of patients with a high risk of relapse, as defined by MonarchE inclusion criteria (1), out of the total number of HR+/ HER2- early breast cancer cases, in four countries: KSA, UAE, Turkey, and India. The study also aims to obtain real world data about the treatment patterns and clinical characteristics in HR+, HER2- early breast cancer patients.
The primary study objective is to describe the proportion of patients with high risk of relapse, as defined by MonarchE inclusion criteria\*, out of the total number of the recruited cases.The study’s secondary objective is to describe the treatment patterns and clinical characteristics in HR+, HER2- early breast cancer patients (EBC)
HR+/ HER2- early breast cancer patients with a high risk of relapse defined as patients with four or more positive pathologic axillary lymph nodes or one to three positive axillary lymph nodes and at least one of the following: tumour size ≥ 5 cm, histologic grade 3, or Ki-67 ≥ 20%.
All study data will be collected retrospectively from the medical records and will cover the period of 2 years before the data collection date, from the date of early breast cancer patients (EBC) patients’ diagnosis until patients’ inclusion dates. Since a predetermined number of cases are sought from each country, then quota sampling will be used. Within each country/site, convenience sampling will be used to collect data from available records.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 550
- Adult women ≥18 years of age (or per local regulations).
- The participant has confirmed HR+, HER2-, early-stage resected invasive breast cancer without evidence of distant metastases.
- The participant must have undergone definitive surgery of the primary breast tumor.
- The participant must have tumor tissue from the breast (preferred) or lymph node.
- Distant metastasis.
- No other explicit exclusion criteria are defined to allow for documentation of routine clinical practice as much as possible.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To describe the proportion of patients with a high risk of relapse, as defined by MonarchE At Baseline, one-time assessment only. inclusion criteria, out of the total number of the recruited cases of HR+, HER2- early At Baseline, one-time assessment only. breast cancer patients (EBC) At Baseline, one-time assessment only.
- Secondary Outcome Measures
Name Time Method To describe the treatment patterns & clinical characteristics in HR positive, HER2 negative early breast cancer patients (EBC).
Trial Locations
- Locations (5)
Basavatarakam Indo American Cancer Hospital & Research Institute
🇮🇳Hyderabad, TELANGANA, India
Christian Medical College
🇮🇳Vellore, TAMIL NADU, India
Rajiv Gandhi Cancer Institute & Research Centre
🇮🇳West, DELHI, India
Tata Medical Center
🇮🇳Kolkata, WEST BENGAL, India
Tata Memorial Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Basavatarakam Indo American Cancer Hospital & Research Institute🇮🇳Hyderabad, TELANGANA, IndiaDr SenthilPrincipal investigator9849213102senthiljrajappa@gmail.com