Locally Advanced Breast CancerPhase 3NCT07024173
A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer
A Phase 3 study testing HRS-8080 Tablet, Fulvestrant injection and Exemestane tablets in people with Locally Advanced Breast Cancer and Metastatic Breast Cancer, run by Shandong Suncadia Medicine Co., Ltd. at 2 sites in China.
Trial summary
This study is a multicenter, open-label, randomized controlled Phase 3 clinical trial. It is planned to enroll 240 female patients with locally advanced or metastatic breast cancer followed by disease progression after previous endocrine therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Locally Advanced Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- HRS-8080 Tablet, Fulvestrant injection and Exemestane tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesChina
- Study dates
- 23 Jul 2025to Dec 2027
- Phase
- Phase 3
- 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 to 75 years old (including both values).
- ECOG Physical Strength Status (PS) : 0 to 1 point.
- Patients with locally advanced or metastatic breast cancer confirmed by histology.
- Patients previously received 1-2 lines of endocrine therapy.
- Patients received no more than one line of chemotherapy in the recurrence/metastasis stage.
- Menstrual status (meeting any of the following conditions) : a) After bilateral ovariectomy; b) Age ≥60 years old; c) Age < 60 years old, natural menopause ≥12 months, without receiving chemotherapy, tamoxifen (TAM), tolemiphene or ovarian castration in the past year, follicle-stimulating hormone (FSH) and estradiol are within the postmenopausal range; d) For patients under the age of 60 who are taking TAM or tolemiphene, the levels of FSH and estradiol are within the postmenopausal range; e) Premenopausal or perimenopausal patients received luteinizing hormone-releasing hormone (LHRH) agonist treatment during the study period, and the treatment was initiated at least 14 days before the start of the study.
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- Patients comply with any of the following provisions of the RECIST v1.1 standard: a) There is at least one extracranial measurable lesion; b) If there are no measurable lesions as stipulated above, at least one osteolytic or mixed (osteolytic and osteogenic) bone lesion that can be evaluated by computed tomography (CT) or magnetic resonance imaging (MRI) exists.
- Expected survival > 6 months.
- The functional level of the organs must meet the requirements.
- Female with fertility must agree to use effective contraceptive measures for contraception during the study treatment period and within 7 months after the end of the study treatment period; Femalewith fertility must have a negative serum human chorionic gonadotropin (hCG) test within 7 days before enrollment in the study and must be in the non-lactation period.
- Voluntarily participate in this clinical trial, be willing and able to abide by the procedures related to clinical visits and research, understand the research procedures and have signed the informed consent.
Who cannot join
- Patients previously received other systemic anti-tumor treatments besides chemotherapy、endocrine therapy and CDK4/6i (prior use of PI3K inhibitors or AKT inhibitors is permitted for patients with known PIK3CA mutations or PIK3CA/AKT/PTEN alterations).
- Nitrosorea or mitomycin was received within 6 weeks before the first study administration in this study; Have undergone major organ surgery, cytotoxic drugs, immunotherapy, , anti-tumor traditional or Chinese medicine medications within 4 weeks before the first study administration and within 4 weeks or 5 half lives (whichever is shorter) prior to the first study drug administration ; Have received endocrine therapy (referring to aromatase inhibitors [AI], etc.) and palliative radiotherapy within 2 weeks before the first study administration.
- the date from the first study administration to the last CYP3A4 strong inducer administration is less than 28 days.
- Patients with rapid disease progression and investigators determines that endocrine therapy is not suitable or tolerant.
- Patients with active (uncontrolled by medical treatment or with clinical symptoms) brain metastases, cancerous meningitis, spinal cord compression, or a history of primary central nervous system tumors; Patients with brain metastases who have completed treatment at least 28 days before the first study administration, have stable symptoms and do not require hormone therapy may be enrolled as appropriate, but they must be confirmed to have no cerebral hemorrhage by cranial imaging examinations such as CT, MRI or venography.
- A history of severe clinical cardiovascular diseases.
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- Patients with uncontrollable tumor-related pain as judged by investigators. Patients who need pain-relieving medication must have a stable pain-relieving medication plan before entering the study.
- Patients who have received immunosuppressant or systemic hormone therapy for immunosuppression within 2 weeks prior to the first medication (dose > 10 mg/d prednisone or other corticosteroid hormones of equivalent physiological dose), excluding nasal sprays or inhaled hormones.
- The damage caused by other treatments previously received by patients did not recover to grade ≤1 in the Common Terminology Criteria for Adverse Events of the National Cancer Institute of the United States, Version 5.0 (NCI CTCAE v5.0) (excluding alopecia and other adverse events judged tolerable by investigators).
- Severe infection exists within 4 weeks before the first study administration, including but not limited to infectious complications requiring hospitalization, bacteremia, severe pneumonia, etc. There was an active infection of CTCAE grade ≥2 requiring intravenous antibiotic treatment within 2 weeks before the first study administration.
- Patients with arterial/venous thrombotic events that occurred within 6 months before the first study administration, such as cerebrovascular accidents, deep vein thrombosis and pulmonary embolism, etc.
- Patients with clinically significant endometrial abnormalities, including but not limited to endometrial hyperplasia and dysfunctional uterine bleeding.
- Untreated active hepatitis.
- Patients with other malignant tumors within the past 5 years or is currently suffering from them, except for cancers with an extremely low risk of recurrence, including but not limited to radical cervical carcinoma in situ, cutaneous basal cell carcinoma and squamous cell carcinoma, and surgically treated papillary thyroid carcinoma, etc.
- Patients with hereditary or acquired bleeding tendency (such as hemophilia, coagulation dysfunction, etc.).
- Patients with a history of active autoimmune diseases, immunodeficiency, or diseases and syndromes requiring systemic steroid hormone or immunosuppressive drug treatment, or having other acquired (human acquired immunodeficiency virus [HIV] infection), congenital immunodeficiency diseases, or a history of organ transplantation (including allogeneic bone marrow transplantation).
- There is one of the multiple factors that affect oral medication (such as inability to swallow and intestinal obstruction, etc.) or there are active gastrointestinal diseases or other diseases that may lead to factors that significantly affect drug absorption, distribution, metabolism or excretion (active, inflammatory bowel disease or chronic diarrhea, enteral syndrome or upper gastrointestinal surgery, including gastrectomy).
- Patients in the acute infection stage or active tuberculosis and requiring drug treatment.
- Patients known to be allergic to the HRS-8080 component.
- Pregnant and lactating women, or those planning to become pregnant during the study period.
- Patients with a clear history of neurological or mental disorders, or patients with a history of drug abuse or psychotropic medication abuse.
- Patients with other serious physical or laboratory examination abnormalities that may increase the risk of participating in the study, or interfere with the research results, as well as those deemed unsuitable for participation in the study by investigators.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410000
Quchang Ouyang, +86-0731-89762160, oyqc1969@126.com
Quchang Ouyang
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Shusen Wang, 13926168469, wangshs@sysucc.org.cn
Wang Shusen
About this study
Official title: A Multicenter, Open-label, Randomized Controlled Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer With Disease Progression After Previous Endocrine Therapy
This study is a multicenter, open-label, randomized controlled Phase 3 clinical trial. It is planned to enroll 240 female patients with locally advanced or metastatic breast cancer followed by disease progression after previous endocrine therapy.
- Being tested
- HRS-8080 Tablet, Fulvestrant injection, Exemestane tablets, Everolimus Tablets, Anastrozole 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 TabletDrug
HRS-8080 tablet orally administered.
Fulvestrant injectionDrug
Fulvestrant injection.
Exemestane tabletsDrug
Exemestane tablets orally administered.
Everolimus TabletsDrug
Everolimus tablets orally administered.
Anastrozole TabletsDrug
Anastrozole tablets orally administered.
Letrozole TabletsDrug
Letrozole tablets orally administered.
| Study group | Role | What they receive |
|---|---|---|
| HRS-8080 Group | Experimental | Not described Receives: Drug: HRS-8080 Tablet |
| Fulvestrant Group | Active comparator | Not described Receives: Drug: Fulvestrant injection |
| Exemestane in combination with Everolimus Group | Active comparator | Not described Receives: Drug: Exemestane tablets; Drug: Everolimus Tablets |
| Exemestane or Anastrozole or Letrozole Group | Active comparator | Not described Receives: Drug: Exemestane tablets; Drug: Anastrozole Tablets; Drug: Letrozole Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) evaluated by the blinded independent central review (BICR).
Measured: Approximately 2 years.
Secondary outcomes (7)
Progression free survival (PFS) evaluated by investigators.
Measured: Approximately 2 years.
Overall response rate (ORR).
Measured: Approximately 2 years.
Clinical benefit rate (CBR).
Measured: Approximately 2 years.
Duration of response (DOR).
Measured: Approximately 2 years.
Overall survival (OS).
Measured: Approximately 3 years.
Adverse events (AEs).
Measured: Approximately 2 years.
Serious adverse events (SAEs).
Measured: Approximately 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start23 Jul 2025
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia Medicine Co., Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024173
- Sponsor's protocol ID
- HRS-8080-303
- Status last verified
- Sep 2026
- First submitted
- 9 Jun 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Randomized Controlled Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer With Disease Progression After Previous Endocrine Therapy
- ClinicalTrials.gov ID
- NCT07024173
- Acronym / sponsor ID
- HRS-8080-303
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Jun 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 a multicenter, open-label, randomized controlled Phase 3 clinical trial. It is planned to enroll 240 female patients with locally advanced or metastatic breast cancer followed by disease progression after previous endocrine therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HRS-8080 Group | Experimental | Drug: HRS-8080 Tablet |
| Fulvestrant Group | Active comparator | Drug: Fulvestrant injection |
| Exemestane in combination with Everolimus Group | Active comparator | Drug: Exemestane tablets, Drug: Everolimus Tablets |
| Exemestane or Anastrozole or Letrozole Group | Active comparator | Drug: Exemestane tablets, Drug: Anastrozole Tablets, Drug: Letrozole Tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Women aged 18 to 75 years old (including both values).
- ECOG Physical Strength Status (PS) : 0 to 1 point.
- Patients with locally advanced or metastatic breast cancer confirmed by histology.
- Patients previously received 1-2 lines of endocrine therapy.
- Patients received no more than one line of chemotherapy in the recurrence/metastasis stage.
Key exclusion criteria (22 listed)
- Patients previously received other systemic anti-tumor treatments besides chemotherapy、endocrine therapy and CDK4/6i (prior use of PI3K inhibitors or AKT inhibitors is permitted for patients with known PIK3CA mutations or PIK3CA/AKT/PTEN alterations).
- Nitrosorea or mitomycin was received within 6 weeks before the first study administration in this study; Have undergone major organ surgery, cytotoxic drugs, immunotherapy, , anti-tumor traditional or Chinese medicine medications within 4 weeks before the first study administration and within 4 weeks or 5 half lives (whichever is shorter) prior to the first study drug administration ; Have received endocrine therapy (referring to aromatase inhibitors [AI], etc.) and palliative radiotherapy within 2 weeks before the first study administration.
- the date from the first study administration to the last CYP3A4 strong inducer administration is less than 28 days.
- Patients with rapid disease progression and investigators determines that endocrine therapy is not suitable or tolerant.
- Patients with active (uncontrolled by medical treatment or with clinical symptoms) brain metastases, cancerous meningitis, spinal cord compression, or a history of primary central nervous system tumors; Patients with brain metastases who have completed treatment at least 28 days before the first study administration, have stable symptoms and do not require hormone therapy may be enrolled as appropriate, but they must be confirmed to have no cerebral hemorrhage by cranial imaging examinations such as CT, MRI or venography.
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 |
|---|---|---|
| HRS-8080 TabletHRS-8080 tablet orally administered. | Drug | HRS-8080 Group |
| Fulvestrant injectionFulvestrant injection. | Drug | Fulvestrant Group |
| Exemestane tabletsExemestane tablets orally administered. | Drug | Exemestane in combination with Everolimus Group, Exemestane or Anastrozole or Letrozole Group |
| Everolimus TabletsEverolimus tablets orally administered. | Drug | Exemestane in combination with Everolimus Group |
| Anastrozole TabletsAnastrozole tablets orally administered. | Drug | Exemestane or Anastrozole or Letrozole Group |
| Letrozole TabletsLetrozole tablets orally administered. | Drug | Exemestane or Anastrozole or Letrozole Group |
Primary outcome
Progression free survival (PFS) evaluated by the blinded independent central review (BICR).
Time frame: Approximately 2 years.
7 secondary outcomes
Progression free survival (PFS) evaluated by investigators.
Time frame: Approximately 2 years.
Overall response rate (ORR).
Time frame: Approximately 2 years.
Clinical benefit rate (CBR).
Time frame: Approximately 2 years.
Duration of response (DOR).
Time frame: Approximately 2 years.
Overall survival (OS).
Time frame: Approximately 3 years.
Adverse events (AEs).
Time frame: Approximately 2 years.
Serious adverse events (SAEs).
Time frame: Approximately 2 years.
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 2 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HRS-8080 Tablet, Fulvestrant injection and Exemestane tablets in people with Locally Advanced Breast Cancer and 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 11 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 2 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 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 (+86-0518-82342973, 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?
Progression free survival (PFS) evaluated by the blinded independent central review (BICR). (time frame: Approximately 2 years.). 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 2 Oct 2026.