Trial Watch: 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
Important context
- Trial eligibility (participation has strict criteria): Clinical-trial participation has study-specific eligibility criteria; registry listing does not mean a person qualifies or should enroll.
In plain English
The 30-second version
What happened?
ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.
Why does it matter?
Phase 3 trials can contribute later-stage human evidence. CancerDiscoveries can track this record as results and regulatory information emerge.
What does this not prove?
A registered trial is not proof that the intervention works, is not FDA approval for this cancer or use, and is not a clinical-guideline recommendation.
Keep reading for evidence stage, limitations, study details, and sources.
What changed: ClinicalTrials.gov lists 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 (NCT07391774) as a Phase 3 interventional cancer study. The registry status is Recruiting, with the record last updated 2026-08-13.
Study snapshot: Phase 3; Recruiting; planned enrollment 1,978. Conditions listed: Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Estrogen Receptor-Positive Breast Carcinoma. A primary outcome listed by the registry is: Invasive breast cancer-free survival (iBCFS).
This entry tracks verified trial-registry facts. Trial registration by itself does not show that an intervention is effective, safe for a particular person, FDA-approved for this use, or recommended by clinical guidelines.
Population / Applicability
Studied in: Participants age 18 Years and older with Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Estrogen Receptor-Positive Breast Carcinoma who meet the study-specific registry eligibility criteria. (Adults)
Eligibility is study-specific. Registry information does not determine whether any individual should enroll in or receive the intervention.
Full evidence details
- Study design
- Not specified in this summary
- Sample size
- 1978
- Primary outcome
- Invasive breast cancer-free survival (iBCFS)
- Replication
- Unknown
Funding & Conflicts
ClinicalTrials.gov lists the lead sponsor as National Cancer Institute (NCI). Sponsorship is reported for transparency and does not establish efficacy.
Regulatory status by jurisdiction
Country or region not specified
- Status
- Investigational
- Last verified
- 2026-08-14
Cancer-type scope for this record is not yet recorded.
Guideline positions
Guideline
- Position
- Not addressed
- Last verified
- 2026-08-14
Primary evidence supporting this story
- ClinicalTrials.gov — NCT07391774 (opens in a new tab) (Clinical-trial registry) NCT07391774 Primary source NCT07391774
ClinicalTrials.gov — NCT07391774. NCT07391774.
Last reviewed
Trial Watch: 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
https://cancerdiscoveries.com/discoveries/trial-watch-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/
Research type: Registered later-phase trial
What This Means
ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.
What This Doesn't Mean
A registered trial is not proof that the intervention works, is not FDA approval for this cancer or use, and is not a clinical-guideline recommendation.
Why It Matters
Phase 3 trials can contribute later-stage human evidence. CancerDiscoveries can track this record as results and regulatory information emerge.
Important Limitations
- Clinical-trial participation has study-specific eligibility criteria; registry listing does not mean a person qualifies or should enroll.
Primary sources
- ClinicalTrials.gov — NCT07391774 — https://clinicaltrials.gov/study/NCT07391774 (NCT07391774)
Date verified: 2026-08-14
Correction status: No correction or retraction