HR+ / HER2 Advanced Breast Cancer / Treatment · Phase 2 Trial

Dalpiciclib Combined With Aromatase Inhibitors and Olmesartan as the First-line Treatment for HR+/HER2- Advanced Breast Cancer

ClinicalTrials.gov · September 9, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned Phase 2 prospective single-arm trial registration for a three-drug combination (dalpiciclib, aromatase inhibitor, olmesartan) in HR+/HER2− advanced breast cancer. No efficacy or safety data are reported in this registry record, which documents the protocol and recruitment status only.

What was studied

Phase 2, Interventional, Single Group, Open label, Treatment purpose. HR+ / HER2- Advanced Breast Cancer; Female; age from 18 Years; to 75 Years. Intervention: treatment. n = 40. 1 site: China.

Key findings

Safety

This is a registry record; no efficacy, safety, or outcome data are reported.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a clinical trial registry record for a planned Phase 2 study with no results posted; it describes the protocol and enrollment target only.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Progession-free survival (assessed at Up to 2 years)

DesignPhase 2, Interventional, Single Group, Open label, Treatment purpose

PopulationHR+ / HER2- Advanced Breast Cancer; Female; age from 18 Years; to 75 Years

Sample size40

Interventiontreatment

Setting1 site: China

Reported figures

Quoted from the source exactly as published.

Planned enrollment40

Primary outcome measureProgression-free survival, up to 2 years

Study phasePhase 2

Caveats

This is a registry record; no efficacy, safety, or outcome data are reported.
Single-arm design permits no direct comparison to standard-of-care aromatase inhibitor monotherapy or established CDK4/6 inhibitor combinations.
Recruitment status is RECRUITING; trial is ongoing and results are not yet available.
Olmesartan (an angiotensin II receptor blocker) use rationale and clinical relevance in breast cancer treatment not explained in this record.

Evidence assessment

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.

Study design

moderate

Prospective single-arm Phase 2; lacks concurrent control arm for comparative inference.

Directness

insufficient

No results reported; cannot assess clinical outcome measurement or relevance.

Consistency

insufficient

Registry record only; no outcome data available for comparison with other studies.

Risk of bias

insufficient

Protocol-stage record; no conduct details or results to assess bias risk.

Sample adequacy

limited

Planned enrollment 40 participants; typical Phase 2 exploratory size, underpowered for confirmatory claims.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07810088). This is a study registration, not published results. Lead sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 40 participants (ESTIMATED). Conditions: HR+ / HER2- Advanced Breast Cancer. Interventions: DRUG: Treatment; DRUG: Treatment; DRUG: Treatment. Primary outcome measures: Progession-free survival , Up to 2 years. Brief summary: This study is a prospective, single-arm, multicenter phase II clinical trial. The study plans to enroll 40 patients with HR+/HER2- advanced breast cancer to explore the efficacy and safety of patients receiving olmesartan, dalpiciclib and aromatase inhibitor treatment.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

HR+ / HER2 Advanced Breast CancerNCT07810088Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyTreatment