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Unresectable or Metastatic Breast CancerPhase 1/2NCT06167694

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

A Phase 1/2 study testing HRS-8080; Dalpiciclib Isethionate Tablets in people with Unresectable or Metastatic Breast Cancer, run by Shandong Suncadia Medicine Co., Ltd. at 2 sites 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 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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Unresectable or Metastatic Breast Cancer
What is being tested?
HRS-8080; Dalpiciclib Isethionate Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
2 sitesChina
Study dates
20 Dec 2023to Jun 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 18-75 years with both ends included.
  • ECOG Physical status 0-1 points.
  • Patients with histologically confirmed metastatic or locally advanced breast cancer.
  • 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.
  • Antitumor therapy with radiographically confirmed disease progression or receiving advanced first-line standard endocrine therapy with no clinical or radiographically confirmed disease progression.
  • At least one measurable extracranial lesion must be present.
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  • Expected survival >3 months.
  • The functional level of the organ must meet the requirements of the test.
  • 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.
  • 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.

Who cannot join

  • Symptoms of visceral metastasis.
  • Previous treatment did not meet trial requirements.
  • 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.
  • 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.
  • 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.
  • A history of clinically severe cardiovascular disease.
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  • Patients with uncontrolled tumor-related pain as judged by the investigator.
  • Those who received immunosuppressive agents or systemic hormone therapy for immunosuppression within 2 weeks prior to the first dose.
  • The damage caused by the subject receiving other treatments has been recovered.
  • Severe infection occurred within 4 weeks prior to the second dose.
  • The first study investigated the occurrence of arteriovenous thrombosis within 6 months prior to medication.
  • Patients with clinically significant endometrial abnormalities.
  • Untreated active hepatitis.
  • Subjects had other malignancies within the past 5 years or currently.
  • Have an inherited or acquired bleeding tendency.
  • History of active autoimmune disease, immune deficiency, and autoimmune disease.
  • One of the many factors that affect oral medications.
  • Subjects are acutely infected or have active TB and require medication.
  • Known allergy to HRS-8080 ingredient, Dalpiciclib and ingredient.
  • Pregnant and lactating women or women planning to become pregnant during the study period.
  • There is a clear history of neurological or psychiatric disorders and the subjects have a history of psychotropic substance abuse or drug use.
  • 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.

Trial locations and contacts

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

Min Li contact

+0518-81220121

min.li.ml150@hengrui.com

China2 sites, 2 recruiting

  • Chinese PLA General Hospital Fifth Medical Center

    Beijing, Beijing Municipality, 100000

    Zefei Jiang, Doctor, +86- 13901372170, jiangzefei@csco.org.cn

    Recruiting

  • Sun Yat-sen University Cancer Center (SYSUCC)

    Guangzhou, Guangdong, 510060

    Shusen Wang, +86-020-87343535, wangshs@sysucc.org.cn

    Shusen Wang

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Being tested
HRS-8080; Dalpiciclib Isethionate Tablets
Medical subject headings
Breast Neoplasms

What participants receive

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

  • HRS-8080; Dalpiciclib Isethionate TabletsDrug

    HRS-8080 combined with Dalpiciclib Isethionate Tablets

Study groups in NCT06167694
Study groupRoleWhat they receive
Treatment group AExperimentalNot described
Receives: Drug: HRS-8080; Dalpiciclib Isethionate Tablets

What is being measured

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

  1. Dose-limiting toxicity (DLT)

    Measured: About 2 years

  2. Maximum tolerated dose (MTD)

    Measured: About 2 years

  3. Recommended phase II dose (RP2D)

    Measured: About 2 years

  4. Safety endpoints: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

    Measured: About 2 years

  5. Outcome endpoint: Objective Response Rate (ORR)

    Measured: About 2 years

Secondary outcomes (9)

  1. Steady-state peak concentration (Cmax,ss)

    Measured: About 2 years

  2. Steady-state peak time (Tmax,ss)

    Measured: About 2 years

  3. Steady-state valley concentration (Cmin,ss)

    Measured: About 2 years

  4. Steady-state blood drug concentration-time curve area (AUCss)

    Measured: About 2 years

  5. Best overall response (BOR)

    Measured: About 2 years

  6. Duration of response (DoR)

    Measured: About 2 years

  7. Disease control rate (DCR)

    Measured: About 2 years

  8. Clinical benefit rate (CBR)

    Measured: About 2 years

  9. Progression-free survival (PFS)

    Measured: About 2 years

Timeline

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

  1. First posted12 Dec 2023
  2. Study start20 Dec 2023
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Multi-center, open clinical study of HRS-8080 in conjunction with Dalpiciclib
Masking
None (open label)
Enrolment
146 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06167694
Sponsor's protocol ID
HRS-8080-201
Status last verified
Jan 2026
First submitted
4 Dec 2023
Last updated
9 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HRS-8080; Dalpiciclib Isethionate Tablets in people with Unresectable or Metastatic Breast Cancer, run by Shandong Suncadia Medicine Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Min Li (+0518-81220121, min.li.ml150@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) (time frame: About 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06167694.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.

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