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A Retrospective Study to Understand the Clinical Characteristics and the Treatment for Breast Cancer Patients

A Retrospective Study to Understand the Clinical Characteristics and the Treatment Patterns For HR positive, HER2 negative High-Risk Early Breast Cancer Patients - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/07/055665
Enrollment
550
Registered
2023-07-25
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: NIL: NIL

Sponsors

Clinart MENA
Lead Sponsor
Fervor Health solutions
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult women >=18 years of age (or per local regulations). 2. The participant has confirmed HR+, HER2-, early-stage resected invasive breast cancer without evidence of distant metastases. 3. The participant must have undergone definitive surgery of the primary breast tumor. 4. The participant must have tumor tissue from the breast (preferred) or lymph node.

Exclusion criteria

Exclusion criteria: 1. Distant metastasis. No other explicit exclusion criteria are defined to allow for documentation of routine clinical practice as much as possible.

Design outcomes

Primary

MeasureTime frame
To describe the proportion of patients with a high risk of relapse, as defined by MonarchE inclusion criteria, out of the total number of the recruited cases of HR+, HER2- early breast cancer patients (EBC)Timepoint: At Baseline, one-time assessment only.—

Secondary

MeasureTime frame
To describe the treatment patterns & clinical characteristics in HR positive, HER2 negative early breast cancer patients (EBC).Timepoint: At Baseline one time assessment only.—

Countries

India, Saudi Arabia, Turkey, United Arab Emirates

Contacts

Public ContactMr Sharad Jain

Fervor Health Solutions Private Limited

tarun@fervorhs.com8860009879

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026