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

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

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.

Study Overview

• Status: Recruiting
• Conditions: HR+ / HER2- Advanced Breast Cancer
• Intervention / Treatment: Drug: Treatment; Drug: Treatment; Drug: Treatment

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: yanxia zhao; Phone Number: +8613407192551; Email: Sophia7781@126.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: yanxia zhao, master; Phone Number: +8613407192551; Email: Sophia7781@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment; dalpiciclib+olmesartan+ letrozole or anastrozole or exemestane or Fulvestrant	Drug: Treatment; dalpiciclib:125mg once a day for 3 weeks and stop for 1 week. Q4W.; Drug: Treatment; Olmesartan:20mg，po，qd，q4w; Drug: Treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall Survival	OS is defined as the time from enrollment to the patient's death due to any cause	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.	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	up to 1 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Treatment-Emergent adverse event rate according to the Common Terminology Criteria for Adverse Events version 5.0	Safety	up to 2 years

Collaborators and Investigators

• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
• Investigators: Principal Investigator: yanxia zhao, master, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2025
• Primary Completion (Estimated): June 28, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: August 24, 2026
• First Submitted That Met QC Criteria: September 8, 2026
• First Posted (Actual): September 9, 2026

Study Record Updates

• Last Update Posted (Actual): September 9, 2026
• Last Update Submitted That Met QC Criteria: September 8, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: olmesartan; HR+/HER2- advanced breast cancer; dalpiciclib
• Additional Relevant MeSH Terms: Therapeutics
• Other Study ID Numbers: OBU-BC-II-205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No