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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast Cancer

A Multicenter, Open Phase Ib/II Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With ER-positive, HER2-negative Unresectable or Metastatic Breast Cancer

Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast Cancer (NCT06167694) is a Phase 1 / Phase 2 interventional studying Unresectable or Metastatic Breast Cancer, sponsored by Shandong Suncadia Medicine Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a multicenter, open phase Ib/II clinical study, which is divided into two phases: dose exploration and efficacy expansion. Participants entering the study will receive HRS-8080 combined with Dalpiciclib Isethionate Tablets therapy.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Unresectable or Metastatic Breast Cancer, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 146 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Unresectable or Metastatic Breast Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Women aged 18-75 years with both ends included. 2. ECOG Physical status 0-1 points. 3. Patients with diagnosed by tissue sample (biopsy-confirmed) metastatic or locally advanced breast cancer. 4. Dose-exploration stage: advanced stage has received at least 1 line of endocrine therapy progression in the past, efficacy extension stage: has not received any systemic treatment for advanced disease5. 5. Antitumor therapy with radiographically confirmed disease progression or receiving advanced first-line standard endocrine therapy with no clinical or radiographically confirmed disease progression. 6. At least one measurable extracranial lesion must be present. 7. Expected survival \>3 months. 8. The functional level of the organ must meet the requirements of the test. 9. Fertile female subjects must consent to use highly effective contraception during the study treatment period and for 7 months after the end of the study treatment period; Fertile female subjects must be negative for serum HCG within 7 days prior to study enrollment and must be non-lactating. 10. Volunteer to participate in this clinical trial, be willing and able to follow clinical visit and study related procedures, understand study procedures and have signed willing to sign a consent form. Who Should NOT Join This Trial: 1. Symptoms of visceral metastasis. 2. Previous treatment did not meet trial requirements. 3. Received nitrosourea or mitomycin within 6 weeks before the first dose in this study; Received major organ surgery, cytotoxic drugs, immunotherapy, targeted therapy, anti-tumor traditional Chinese medicine or other clinical investigational drugs within 4 weeks before the first medication; He received endocrine therapy and palliative radiotherapy within 2 weeks before the first dose. 4. Less than 14 days after the first dose of CYP3A4; CYP3A4 is treated with a strong inducer \<28 days from the date of first administration. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Women aged 18-75 years with both ends included. 2. ECOG Physical status 0-1 points. 3. Patients with histologically confirmed metastatic or locally advanced breast cancer. 4. Dose-exploration stage: advanced stage has received at least 1 line of endocrine therapy progression in the past, efficacy extension stage: has not received any systemic treatment for advanced disease5. 5. Antitumor therapy with radiographically confirmed disease progression or receiving advanced first-line standard endocrine therapy with no clinical or radiographically confirmed disease progression. 6. At least one measurable extracranial lesion must be present. 7. Expected survival \>3 months. 8. The functional level of the organ must meet the requirements of the test. 9. Fertile female subjects must consent to use highly effective contraception during the study treatment period and for 7 months after the end of the study treatment period; Fertile female subjects must be negative for serum HCG within 7 days prior to study enrollment and must be non-lactating. 10. Volunteer to participate in this clinical trial, be willing and able to follow clinical visit and study related procedures, understand study procedures and have signed informed consent. Exclusion Criteria: 1. Symptoms of visceral metastasis. 2. Previous treatment did not meet trial requirements. 3. Received nitrosourea or mitomycin within 6 weeks before the first dose in this study; Received major organ surgery, cytotoxic drugs, immunotherapy, targeted therapy, anti-tumor traditional Chinese medicine or other clinical investigational drugs within 4 weeks before the first medication; He received endocrine therapy and palliative radiotherapy within 2 weeks before the first dose. 4. Less than 14 days after the first dose of CYP3A4; CYP3A4 is treated with a strong inducer \<28 days from the date of first administration. 5. Patients with active (untreated or clinically symptomatic) brain metastases, cancerous meningitis, spinal cord compression, or a history of primary tumors of the central nervous system. 6. A history of clinically severe cardiovascular disease. 7. Patients with uncontrolled tumor-related pain as judged by the investigator. 8. Those who received immunosuppressive agents or systemic hormone therapy for immunosuppression within 2 weeks prior to the first dose. 9. The damage caused by the subject receiving other treatments has been recovered. 10. Severe infection occurred within 4 weeks prior to the second dose. 11. The first study investigated the occurrence of arteriovenous thrombosis within 6 months prior to medication. 12. Patients with clinically significant endometrial abnormalities. 13. Untreated active hepatitis. 14. Subjects had other malignancies within the past 5 years or currently. 15. Have an inherited or acquired bleeding tendency. 16. History of active autoimmune disease, immune deficiency, and autoimmune disease. 17. One of the many factors that affect oral medications. 18. Subjects are acutely infected or have active TB and require medication. 19. Known allergy to HRS-8080 ingredient, Dalpiciclib and ingredient. 20. Pregnant and lactating women or women planning to become pregnant during the study period. 21. There is a clear history of neurological or psychiatric disorders and the subjects have a history of psychotropic substance abuse or drug use. 22. The presence of other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of participating in the study or interfere with the study results, as well as patients deemed unsuitable for participation in this study by the investigator.

Treatments Being Tested

DRUG

HRS-8080; Dalpiciclib Isethionate Tablets

HRS-8080 combined with Dalpiciclib Isethionate Tablets

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Chinese PLA General Hospital Fifth Medical Center
Beijing, Beijing Municipality, China
Sun Yat-sen University Cancer Center (SYSUCC)
Guangzhou, Guangdong, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06167694), the sponsor (Shandong Suncadia Medicine Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06167694 clinical trial studying?

This is a multicenter, open phase Ib/II clinical study, which is divided into two phases: dose exploration and efficacy expansion. Participants entering the study will receive HRS-8080 combined with Dalpiciclib Isethionate Tablets therapy. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06167694?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06167694?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06167694. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06167694. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.