Advanced Breast CancerPhase 2NCT07125950
SHR2554 Combined With Endocrine Therapy in Advanced Breast Cancer
A Phase 2 study testing SHR2554 and HRS-8080 in people with Advanced Breast Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
This study is aimed to evaluate the safety and preliminary of all-oral regimen SHR2554 combined with HRS-8080 in advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- SHR2554 and HRS-8080
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 14 Oct 2025to 31 Jan 2028
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old, patients with advanced or metastatic breast cancer;
- ECOG PS Score: 0~1;
- Based on RECIST v1.1, at least one measurable lesion;
- Patients must have a life expectancy ≥ 3 months;
- Adequate organ function and marrow function (no corrective treatment within 14 days before first dose);
- Women of childbearing potential (WOCBP) should agree to use an effective method of contraception and no lactation from the initiation of screening to 7 months after the last dose of study therapy; WOCBP should have a negative serum pregnancy result within 7 days before the first dose of study therapy; if unneutered male subjects (including using other sterilization except bilateral orchidectomy [e.g. vasectomy]) are willing to have sexual behaviour with WOCBP, one kind of contraception must be used to prevent the pregnancy of his partner from the date of enrolment to 7 months after the last dose of study therapy);
- Willing and able to provide written informed consent and comply with the requirements and restrictions in the protocol.
Who cannot join
- Has received or been receiving ADC therapy;
- Active brain metastasis (without medical control or having clinical symptoms), carcinomatous meningitis or spinal compression;
- Existence of third space fluid (e.g. massive ascites, pleural effusion) which is not well controlled by effective methods, e.g. drainage, evaluated by investigators;
- Other malignancy within prior 2 years with no necessary treatment (except hormone replacement treatment) for at least recent 2 years, except: curatively treated in situ cancer of the cervix, skin basal cell carcinoma, skin squamous cell carcinoma or papillary thyroid carcinoma;
- Has received antitumor surgery, radiotherapy, chemotherapy, targeted therapy or immunological therapy within 2 weeks or 5-fold half-life of drugs (whichever is shorter) before first dose of study therapy; has received antitumor endocrine therapy within one week before first dose of study therapy;
- Adverse events caused by prior antitumor therapy have not recovered to ≤grade 1 per NCI-CTCAE v5.0 (except alopecia and tolerable, chronic grade 2 toxicity determined by investigator);
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- Use of other antitumor systemic treatment during the study;
- Has received CYP3A4 median or potent inhibitors within 2 weeks before the first dose, or CYP3A4 median or potent inducers within 4 weeks before the first dose, or been receiving known CYP3A5 median or potent inhibitors or inducers;
- Hypersensitivity to study therapy or any of its excipients;
- Uncontrolled chronic, systemic complicating disease evaluated by investigators (e.g. severe, chronic pulmonary, hepatic, renal or heart disease);
- Known history of immunodeficiency, including HIV-positive, other acquired or innate immunodeficient disease, or known history of organ transplantation, or known history of allogenic haemopoietic stem cell transplantation;
- Has active hepatitis B (HBsAg-positive and HBV DNA≥500 IU/mL), hepatitis C (positive for HCV antibody and HCV RNA above ULN) and hepatic cirrhosis;
- Has an active infection requiring antibiotics, antiviral or antifungal treatment, or pyrexia >38.5℃ of unknown origin during the screening period before first dose of study therapy (patients with pyrexia due to cancer could be enrolled determined by investigator);
- Known clinically severe cardiac-cerebral vascular disease, including: (1) congestive heart failure (NYHA Class >2); (2) unstable angina pectoris; (3) myocardial infarction over the past year; (4) any supraventricular or ventricular arrhythmia needed to treat or intervene; ECG abnormality of clinical significance evaluated by investigators; existence of arterial/venous thrombotic event within 6 months before first dose, or cerebrovascular accidents, or transient ischemic attack;
- Inability to take oral medication (e.g., unable to swallow, intestinal obstruction), or any active gastrointestinal disease or other condition resulting in inability to drug absorption, distribution, metabolism or excretion (e.g., active gastroenteritis, chronic diarrhoea, intestinal syndrome, or upper gastrointestinal surgery, including gastrectomy);
- Other conditions that might influence the study and analysis of results in the opinion of 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.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Min Yan, Chief physician, +86-15713857388, ym200678@126.com
Limin Niu, Physician-in-charge, +86-15838271475, 1412113302@qq.com
About this study
Official title: A Phase 2 Trial of SHR2554 Combined With Endocrine Therapy in Advanced Breast Cancer
This study is aimed to evaluate the safety and preliminary of all-oral regimen SHR2554 combined with HRS-8080 in advanced breast cancer.
- Conditions
- Advanced Breast Cancer
- Being tested
- SHR2554, HRS-8080
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR2554Drug
SHR2554
HRS-8080Drug
HRS-8080
| Study group | Role | What they receive |
|---|---|---|
| SHR2554 + HRS-8080 | Experimental | SHR2554 + HRS-8080 Receives: Drug: SHR2554; Drug: HRS-8080 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR by investigator
ORR is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response) or PR (partial response) per RECIST v1.1.
Measured: At baseline, at the time point of every 8 weeks within first 24 weeks, thereafter every 12 weeks
Secondary outcomes (5)
CBR by investigator
CBR is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response), PR (partial response) or SD (stable disease)≥6 months per RECIST v1.1.
Measured: At baseline, at the time point of every 8 weeks within first 24 weeks, thereafter every 12 weeks
DoR
DoR is the time from the date of first detection of objective response (which is subsequently confirmed) until the date of objective radiographic disease progression.
Measured: up to 3 years
PFS
PFS is the time from the date of first dose until the date of objective radiographic disease progression or death (by any cause in the absence of progression).
Measured: up to 3 years
OS
OS is the time from the date of first dose until the date of death by any cause.
Measured: up to 3 years
Safety (Proportion of AEs)
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Percentage of participants who experienced an adverse event and discontinued study drug due to an AE.
Measured: from time of informed consent provided to 30 days after the last dose of study therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start14 Oct 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Min Yan, MD, Henan Cancer Hospital
- Investigators
- Min Yan, Chief physician, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125950
- Sponsor's protocol ID
- BC-IIT-SHR2554-ET
- Status last verified
- Oct 2026
- First submitted
- 6 Aug 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial of SHR2554 Combined With Endocrine Therapy in Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT07125950
- Acronym / sponsor ID
- BC-IIT-SHR2554-ET
- Conditions
- Advanced Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is aimed to evaluate the safety and preliminary of all-oral regimen SHR2554 combined with HRS-8080 in advanced breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR2554 + HRS-8080 | Experimental | Drug: SHR2554, Drug: HRS-8080SHR2554 + HRS-8080 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 18 years old, patients with advanced or metastatic breast cancer;
- ECOG PS Score: 0~1;
- Based on RECIST v1.1, at least one measurable lesion;
- Patients must have a life expectancy ≥ 3 months;
- Adequate organ function and marrow function (no corrective treatment within 14 days before first dose);
Key exclusion criteria (16 listed)
- Has received or been receiving ADC therapy;
- Active brain metastasis (without medical control or having clinical symptoms), carcinomatous meningitis or spinal compression;
- Existence of third space fluid (e.g. massive ascites, pleural effusion) which is not well controlled by effective methods, e.g. drainage, evaluated by investigators;
- Other malignancy within prior 2 years with no necessary treatment (except hormone replacement treatment) for at least recent 2 years, except: curatively treated in situ cancer of the cervix, skin basal cell carcinoma, skin squamous cell carcinoma or papillary thyroid carcinoma;
- Has received antitumor surgery, radiotherapy, chemotherapy, targeted therapy or immunological therapy within 2 weeks or 5-fold half-life of drugs (whichever is shorter) before first dose of study therapy; has received antitumor endocrine therapy within one week before first dose of study therapy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR2554SHR2554 | Drug | SHR2554 + HRS-8080 |
| HRS-8080HRS-8080 | Drug | SHR2554 + HRS-8080 |
Primary outcome
ORR by investigator
Time frame: At baseline, at the time point of every 8 weeks within first 24 weeks, thereafter every 12 weeks
ORR is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response) or PR (partial response) per RECIST v1.1.
5 secondary outcomes
CBR by investigator
Time frame: At baseline, at the time point of every 8 weeks within first 24 weeks, thereafter every 12 weeks
DoR
Time frame: up to 3 years
PFS
Time frame: up to 3 years
OS
Time frame: up to 3 years
Safety (Proportion of AEs)
Time frame: from time of informed consent provided to 30 days after the last dose of study therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Min Yan, Chief physician principal investigator
Henan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR2554 and HRS-8080 in people with Advanced Breast Cancer, run by Henan Cancer Hospital at 1 site 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 7 inclusion and 16 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 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
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 Yan, Chief physician (+86-15713857388, ym200678@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR by investigator (time frame: At baseline, at the time point of every 8 weeks within first 24 weeks, thereafter every 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2026.