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NCT07391774 · ClinicalTrials.gov registry record · Phase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,978
- Enrollment target
NCT07391774: Recruiting Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT07391774 is a Phase 3 study that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 1,978 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (156% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07391774, a Phase 3 study, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,978 participants
- Enrollment target
Study Summary
This phase III trial compares standard of care hormone therapy plus ribociclib to chemotherapy followed by hormone therapy plus ribociclib for the treatment of patients with high anatomic stage breast cancer with low risk of the cancer returning (low risk recurrence). Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy, with letrozole, anastrozole or exemestane, lowers the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Hormone therapy plus ribociclib may work as well as chemotherapy followed by hormone therapy plus ribociclib for the treatment of high anatomic stage breast cancer with low recurrence risk.
Primary Outcome
Invasive disease defined as the first occurrence of one of the following events: local invasive recurrence following mastectomy, local invasive recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, or contralateral invasive breast cancer. The distribution of iBCFS will be estimated using the Kaplan-Meier method. The hazard ratio will be estimated using Cox proportional hazard model. The primary analysis will compare treatment groups defined by the ra
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Bone Scan
- DRUG Anastrozole
- DRUG Chemotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,978 participants |
| Start Date | 2027-02-14 |
| Est. Completion | 2029-07-31 |
| Phase | Phase 3 |
What NCT07391774 shows while recruiting
NCT07391774 is an interventional study that assigns participants to a tested intervention. Its 1,978 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (156% higher).
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07391774 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07391774 about?
NCT07391774 is a clinical study titled "Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial". This phase III trial compares standard of care hormone therapy plus ribociclib to chemotherapy followed by hormone therapy plus ribociclib for the treatment of patients with high anatomic stage breast cancer with low risk of the cancer returning (low risk recurrence). Ribociclib may stop the growth ...
What is the current status of trial NCT07391774?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,978 participants. The study started on 2027-02-14. Estimated completion is 2029-07-31.
What interventions are being tested in trial NCT07391774?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Bone Scan (PROCEDURE), Anastrozole (DRUG), Chemotherapy (DRUG).
Who is sponsoring clinical trial NCT07391774?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07391774's enrollment target sits among peer trials
1,978 107th of 2000 higher than 1,894 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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