HR+ / HER2- Advanced Breast CancerPhase 2NCT07810088

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

A Phase 2 study testing Treatment in people with HR+ / HER2- Advanced Breast Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years, women only
Conditions the study is for: HR+ / HER2- Advanced Breast Cancer
What is being tested?: Treatment
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteChina
Study dates: 28 Jun 2025to 1 Dec 2028
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Women aged 18 to 75 years, either pre-menopausal/post-menopausal or post-menopausal.
Histologically confirmed HR+/HER2- locally advanced or metastatic breast cancer. Specific definition: Immunohistochemical detection of ER > 10% positive tumor cells is defined as ER positive, PR > 10% positive tumor cells is defined as PR positive, and ER and/or PR positive is defined as HR positive; HER2 0-1+ or HER2 ++ but negative after FISH detection without amplification is defined as HER2 negative;
Have not received any systemic treatment for local recurrence or metastatic diseases before.
Recurrence occurred more than 12 months after the completion of adjuvant endocrine therapy.
According to the RECIST 1.1 , at least one measurable lesion.
Eastern Cooperative Oncology Group (ECOG) physical condition score is 0-1.

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The functional of organs are normal:
Pregnant women of childbearing age must have undergone a serum pregnancy test 28 days before enrollment, and the result is negative. patients are willing to use a medically approved highly effective contraceptive method during the study period and within 1 year after the last administration of the study drug.
Non-pregnant or non-lactating female patients.
Not participating in other ongoing studies .
With the consent of the patient or their legal representative and having signed the informed consent form, willing and capable of following the planned visits, study treatment plan, laboratory tests and other trial procedures.

Who cannot join

Any evidence of severe or uncontrollable systemic diseases, including active bleeding disorders, active infections (such as hepatitis B, hepatitis C and human immunodeficiency virus), or severe damage to bone marrow reserves or organ functions (such as liver and kidney damage).
Previous use of CDK4/6 inhibitors.
Active brain metastases or meningeal brain metastases.
Upper limb arterial blood pressure lower than 90/60 mmHg.
Any history of malignant tumors other than breast cancer within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma.
Severe pneumonia history such as interstitial pneumonia.

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At the time of starting the study treatment, the patient has not recovered from any CTCAE ≥ 3 grade toxicity caused by previous treatment.
Had any heart disease, including: (1) requiring drug treatment or clinically significant arrhythmia; (2) myocardial infarction; (3) heart failure; (4) any other heart disease judged by the researcher or sponsor as not suitable for participating in this trial; etc.
Significant comorbidities, including mental disorders that the investigator or sponsor considers would adversely affect the patient's participation in the study.
History of immunodeficiency diseases, including positive HIV testing, or having other acquired or congenital immune deficiency diseases, or having a history of organ transplantation and allogeneic bone marrow transplantation; history of interstitial lung disease, non-infectious pneumonia.
Patients considered not suitable for inclusion by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

yanxia zhao contact

+8613407192551

Sophia7781@126.com

China1 site, 1 recruiting

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
yanxia zhao, master, +8613407192551, Sophia7781@126.com
Recruiting

Other trials in China

About this study

Official title: A Multicenter, Single-arm, Phase II Clinical Study of Dalpiciclib Combined With Aromatase Inhibitors and Olmesartan as the First-line Treatment for HR+/HER2- Advanced Breast Cancer

Conditions: HR+ / HER2- Advanced Breast Cancer
Being tested: Treatment
Keywords: dalpiciclib, olmesartan, HR+/HER2- advanced breast cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TreatmentDrug
dalpiciclib:125mg once a day for 3 weeks and stop for 1 week. Q4W.
TreatmentDrug
Olmesartan:20mg，po，qd，q4w
TreatmentDrug
Letrozole：2.5mg，q4w or Anastrozole：1mg，q4w or Exemestane：25mg，q4w or Fulvestrant:Patients will receive intramuscular Fulvestrant on day 1 and day 15 of the first cycle and then on day 1 of each subsequent 4-week cycle.

Study groups in NCT07810088
Study group	Role	What they receive
treatment	Experimental	dalpiciclib+olmesartan+ letrozole or anastrozole or exemestane or Fulvestrant Receives: Drug: Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Progession-free survival
PFS is defined as the time from enrollment to the first imaging disease progression or death (whichever occurs first). Assessed according to RECIST v1.1 by investigator.
Measured: Up to 2 years

Secondary outcomes (3)

overall Survival
OS is defined as the time from enrollment to the patient's death due to any cause
Measured: up tp 3 years
Objective response rate(ORR)
ORR is defined as the proportion of patients with complete response(CR) and partial response(PR) assessed by the investigator in accordance with the RECIST 1.1 criteria.
Measured: up to 1 years
Disease control rate(DCR)
ORR is defined as the proportion of patients with complete response(CR) and partial response(PR) and stable disease(SD) assessed by the investigator in accordance with the RECIST 1.1 criteria
Measured: up to 1 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jun 20251 Dec 2028

First posted9 Sep 2026
Study start28 Jun 2025
Primary completion28 Jun 2028 (estimated)
Study completion1 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HR+ / HER2- Advanced Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07810088
Sponsor's protocol ID: OBU-BC-II-205
Status last verified: Sep 2026
First submitted: 24 Aug 2026
Last updated: 9 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

yanxia zhao

+8613407192551

Sophia7781@126.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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