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NCT07363434 · ClinicalTrials.gov registry record
A Real-world Study of Indian Patients With Advanced Breast Cancer Treated With Ribociclib
A clinical trial, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- 335
- Enrollment target
NCT07363434: Completed study, sponsored by Novartis Pharmaceuticals.
NCT07363434 is a clinical trial that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 335 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07363434 has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- 335 participants
- Enrollment target
Study Summary
The aim of this study was to assess the effectiveness, safety, and tolerability of ribociclib in Indian women with hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (aBC). This study used secondary data sources, i.e., paper-based records; electronic medical records (EMRs); and other sources, such as radiology reports, pathology reports, and examination/clinician notes related to aBC, from clinics/hospitals across 18 sites in India. Aggregated data of anonymized patients treated with ribociclib plus endocrine therapy (ET) by the approved indication between June 2018 and December 2021 were collected and analyzed.
Primary Outcome
rwPFS was defined as the time from the start of ribociclib treatment in combination with ET to disease progression, as assessed by the treating physician, or death due to any cause.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 335 participants |
| Start Date | 2022-12-21 |
| Est. Completion | 2024-07-26 |
What the finished NCT07363434 record still lists
NCT07363434 is an observational study that tracks outcomes without assigning an intervention. The registered 335 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT07363434 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07363434 about?
NCT07363434 is a clinical study titled "A Real-world Study of Indian Patients With Advanced Breast Cancer Treated With Ribociclib". The aim of this study was to assess the effectiveness, safety, and tolerability of ribociclib in Indian women with hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (aBC). This study used secondary data sources, i.e., paper-based re...
What is the current status of trial NCT07363434?
This trial is currently completed. The enrollment target is 335 participants. The study started on 2022-12-21. Estimated completion is 2024-07-26.
Who is sponsoring clinical trial NCT07363434?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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