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Culmerciclib / Aromatase Inhibitor (AI) / Early Stage Breast Cancer · Phase 2 Trial
ClinicalTrials.gov · September 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned Phase 2 trial registration with no results posted. The study will evaluate neoadjuvant culmerciclib combined with aromatase inhibitor versus AI monotherapy in HR+/HER2− early-stage breast cancer, with RCB grade 0 or 1 as the primary endpoint. No efficacy or safety data are available from this registry record.
Phase 2, Interventional, Randomized, Parallel, Open label, Treatment purpose. Hormone Receptor-Positive Breast Cancer, HER2 Low Breast Carcinoma, Early-Stage Breast Cancer; Female; age from 18 Years; to 70 Years. Intervention: Culmerciclib combined with aromatase inhibitor. Compared with: Aromatase inhibitor — Active Comparator. n = 80. 1 site: China.
This is a planned Phase 2 trial registration with no results posted. The study will evaluate neoadjuvant culmerciclib combined with aromatase inhibitor versus AI monotherapy in HR+/HER2− early-stage breast cancer, with RCB grade 0 or 1 as the primary endpoint. No efficacy or safety data are available from this registry record.
No comparator arm efficacy or safety data available; outcome reporting awaited
The source did not state who this applies to in practice.
This is a planned Phase 2 trial with no results posted; it describes the protocol and primary endpoint only, making it preliminary evidence at best once data become available.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07796880). This is a study registration, not published results. Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 80 participants (ESTIMATED). Conditions: Hormone Receptor-Positive Breast Cancer, HER2 Low Breast Carcinoma, Early-Stage Breast Cancer. Interventions: DRUG: Culmerciclib; DRUG: Aromatase Inhibitor (AI). Primary outcome measures: Rate of participants achieving Residual Cancer Burden (RCB) grade 0 or 1 , Within 4 weeks after surgery. Brief summary: This is a single-center, open-label, randomized phase II clinical trial designed to evaluate the efficacy and safety of neoadjuvant Culmerciclib combined with aromatase inhibitor versus aromatase-inhibitor monotherapy in patients with Hormone Receptor-positive, Human Epidermal Growth Factor Receptor 2-negative early-stage breast cancer.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.