Please sign in to follow a disease.
Blood pressure drug olmesartan joins breast cancer combo in new trial
NCT ID NCT07810088
First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time
Summary
Researchers are testing whether adding the blood pressure drug olmesartan to dalpiciclib and standard hormone therapy helps women with HR+/HER2- advanced breast cancer. The trial enrolls 40 women aged 18 to 75 with locally advanced or metastatic disease. Everyone receives the three-drug combination, and researchers track how long participants live without their cancer worsening.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dalpiciclib combined with an aromatase inhibitor and olmesartan
- What this could lead to
- If the combination works, it could offer a new first-line option that delays cancer growth for women with HR+/HER2- advanced breast cancer.
- What could go wrong
- This is a small, single-arm phase II trial with no comparison group, so any benefit seen may not hold up in larger randomized studies. Adding olmesartan could also cause low blood pressure or kidney effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2025
- Expected to finish
-
Dec 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Women aged 18 to 75 years, either pre-menopausal/post-menopausal or post-menopausal. 2. 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; 3. Have not received any systemic treatment for local recurrence or metastatic diseases before. 4. Recurrence occurred more than 12 months after the completion of adjuvant endocrine therapy. 5. According to the RECIST 1.1 , at least one measurable lesion. 6. Eastern Cooperative Oncology Group (ECOG) physical condition score is 0-1. 7. The functional of organs are normal: 8. 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. 9. Non-pregnant or non-lactating female patients. 10. Not participating in other ongoing studies . 11. 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. Exclusion Criteria: 1. 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). 2. Previous use of CDK4/6 inhibitors. 3. Active brain metastases or meningeal brain metastases. 4. Upper limb arterial blood pressure lower than 90/60 mmHg. 5. 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. 6. Severe pneumonia history such as interstitial pneumonia. 7. At the time of starting the study treatment, the patient has not recovered from any CTCAE ≥ 3 grade toxicity caused by previous treatment. 8. 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. 9. Significant comorbidities, including mental disorders that the investigator or sponsor considers would adversely affect the patient's participation in the study. 10. 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. 11. Patients considered not suitable for inclusion by the investigator.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for HR+ / HER2- advanced breast cancer are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITINGWuhan, Hubei, 430000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new pill tame advanced breast cancer?
- Real-world data may reveal true effectiveness of leading breast cancer therapy
- New drug combo shows promise for Hard-to-Treat breast cancer
- New pill combo aims to fight Hard-to-Treat breast cancer
- Real-world data on palbociclib combo for breast cancer in japan
- New pill shows promise against resistant cancers in early trial