Breast CancerPhase 3NCT07349069
A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer
A Phase 3 study testing HRS-8080 Tablets, Letrozole tablets and Tamoxifen Citrate Tablets in people with Breast Cancer, run by Shandong Suncadia Medicine Co., Ltd. at 2 sites in China.
Trial summary
The study is being conducted to evaluate the efficacy and safety of HRS-8080 in patients with intermediate or high risk early breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- HRS-8080 Tablets, Letrozole tablets and Tamoxifen Citrate Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,500 participants
- Where
- 2 sitesChina
- Study dates
- 4 Mar 2026to Jan 2034
- 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
- Female patients aged ≥ 18 and ≤ 75 years. Premenopausal patients must meet the eligibility of LHRH agonist therapy during the study period.
- Histologically confirmed invasive breast cancer by postoperative pathology, having received at least 2 years, but no more than 5 years, of adjuvant endocrine therapy.
- No evidence of recurrent or metastatic disease after surgery.
- ECOG performance status of 0 or 1.
- Adequate organ and bone marrow function.
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization and be willing to use acceptable non-hormonal contraception methods from the time of informed consent until 7 months after the last dose of the study drug.
- Any acute toxicities from previous anti-tumor therapy have resolved to Grade 0-1 (per CTCAE v5.0).
- The patient has provided written informed consent (ICF), and is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Who cannot join
- Tumor clinical stage IV (metastatic) breast cancer.
- History and/or treatment of any malignancy other than breast cancer within 5 years prior to randomization.
- History of severe pulmonary disease, such as interstitial lung disease.
- Concurrent or potential use of any anti-tumor therapy not specified in the study protocol.
- Major surgical procedure within 4 weeks prior to randomization.
- HIV infection or known AIDS, active hepatitis B, hepatitis C, or co-infection with hepatitis B and C.
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- Poor cardiac function.
- Severe infection within 4 weeks prior to randomization.
- History of drug allergy.
- History of organ transplantation.
- History of substance abuse.
- Women within 1 year postpartum or who are currently breastfeeding.
- Patients deemed by the investigator as unsuitable for participation in this study.
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
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Qiang Ding, +86-025-68306259, q.ding@hotmail.com
Qiang Ding
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Zhimin Shao, +86-021-64175590, szmgcp2016@163.com
Keda Yu, +86-021-64175590, yukeda@163.com
About this study
Official title: A Randomized, Open-Label, Phase III Trial to Compare HRS-8080 Versus Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer Who Have Received at Least 2 Years of Standard Adjuvant Endocrine Therapy
The study is being conducted to evaluate the efficacy and safety of HRS-8080 in patients with intermediate or high risk early breast cancer.
- Conditions
- Breast Cancer
- Being tested
- HRS-8080 Tablets, Letrozole tablets, Tamoxifen Citrate Tablets, Anastrozole Tablets, Exemestane 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 TabletsDrug
HRS-8080 tablets.
Letrozole tabletsDrug
Letrozole tablets.
Tamoxifen Citrate TabletsDrug
Tamoxifen Citrate tablets.
Anastrozole TabletsDrug
Anastrozole tablets.
Exemestane tabletsDrug
Exemestane tablets.
| Study group | Role | What they receive |
|---|---|---|
| HRS-8080 Group | Experimental | HRS-8080 tablets group. Receives: Drug: HRS-8080 Tablets |
| Standard endocrine therapy Group | Active comparator | Standard endocrine therapy: Letrozole tablets or Tamoxifen Citrate tablets or Anastrozole tablets or Exemestane tablets. Receives: Drug: Letrozole tablets; Drug: Tamoxifen Citrate Tablets; Drug: Anastrozole Tablets; Drug: Exemestane tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time from the date of randomization to the first occurrence of any of the following events: ipsilateral local or contralateral invasive recurrence, distant recurrence, or death from any cause.
Invasive Breast Cancer-Free Survival (IBCFS).
Measured: At Week 24, Week 56, Week 80, and Week 104 during the initial 104-week period, and then every 52 weeks thereafter, up to 5 years.
Secondary outcomes (3)
Invasive Disease-Free Survival (IDFS).
Measured: At Week 24, Week 56, Week 80, and Week 104 during the initial 104-week period, and then every 52 weeks thereafter, up to 5 years.
Distant Metastasis-Free Survival (DRFS).
Measured: At Week 24, Week 56, Week 80, and Week 104 during the initial 104-week period, and then every 52 weeks thereafter, up to 5 years.
Overall Survival (OS).
Measured: Survival follow-up every 3 months, up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start4 Mar 2026
- Primary completionDec 2030 (estimated)
- Study completionJan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 5,500 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
- NCT07349069
- Sponsor's protocol ID
- HRS-8080-305
- Status last verified
- May 2026
- First submitted
- 9 Jan 2026
- Last updated
- 22 May 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Phase III Trial to Compare HRS-8080 Versus Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer Who Have Received at Least 2 Years of Standard Adjuvant Endocrine Therapy
- ClinicalTrials.gov ID
- NCT07349069
- Acronym / sponsor ID
- HRS-8080-305
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,500 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Jan 2034 (estimated)
- First posted
- 16 Jan 2026 (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.
The study is being conducted to evaluate the efficacy and safety of HRS-8080 in patients with intermediate or high risk early breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRS-8080 Group | Experimental | Drug: HRS-8080 TabletsHRS-8080 tablets group. |
| Standard endocrine therapy Group | Active comparator | Drug: Letrozole tablets, Drug: Tamoxifen Citrate Tablets, Drug: Anastrozole Tablets, Drug: Exemestane tabletsStandard endocrine therapy: Letrozole tablets or Tamoxifen Citrate tablets or Anastrozole tablets or Exemestane tablets. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female patients aged ≥ 18 and ≤ 75 years. Premenopausal patients must meet the eligibility of LHRH agonist therapy during the study period.
- Histologically confirmed invasive breast cancer by postoperative pathology, having received at least 2 years, but no more than 5 years, of adjuvant endocrine therapy.
- No evidence of recurrent or metastatic disease after surgery.
- ECOG performance status of 0 or 1.
- Adequate organ and bone marrow function.
Key exclusion criteria (13 listed)
- Tumor clinical stage IV (metastatic) breast cancer.
- History and/or treatment of any malignancy other than breast cancer within 5 years prior to randomization.
- History of severe pulmonary disease, such as interstitial lung disease.
- Concurrent or potential use of any anti-tumor therapy not specified in the study protocol.
- Major surgical procedure within 4 weeks prior to randomization.
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 TabletsHRS-8080 tablets. | Drug | HRS-8080 Group |
| Letrozole tabletsLetrozole tablets. | Drug | Standard endocrine therapy Group |
| Tamoxifen Citrate TabletsTamoxifen Citrate tablets. | Drug | Standard endocrine therapy Group |
| Anastrozole TabletsAnastrozole tablets. | Drug | Standard endocrine therapy Group |
| Exemestane tabletsExemestane tablets. | Drug | Standard endocrine therapy Group |
Primary outcome
The time from the date of randomization to the first occurrence of any of the following events: ipsilateral local or contralateral invasive recurrence, distant recurrence, or death from any cause.
Time frame: At Week 24, Week 56, Week 80, and Week 104 during the initial 104-week period, and then every 52 weeks thereafter, up to 5 years.
Invasive Breast Cancer-Free Survival (IBCFS).
3 secondary outcomes
Invasive Disease-Free Survival (IDFS).
Time frame: At Week 24, Week 56, Week 80, and Week 104 during the initial 104-week period, and then every 52 weeks thereafter, up to 5 years.
Distant Metastasis-Free Survival (DRFS).
Time frame: At Week 24, Week 56, Week 80, and Week 104 during the initial 104-week period, and then every 52 weeks thereafter, up to 5 years.
Overall Survival (OS).
Time frame: Survival follow-up every 3 months, up to 5 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 22 May 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 Tablets, Letrozole tablets and Tamoxifen Citrate Tablets in people with 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 8 inclusion and 13 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 22 May 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 Yue He (+86-0518-82342973, yue.he.yh58@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time from the date of randomization to the first occurrence of any of the following events: ipsilateral local or contralateral invasive recurrence, distant recurrence, or death from any cause. (time frame: At Week 24, Week 56, Week 80, and Week 104 during the initial 104-week period, and then every 52 weeks thereafter, up to 5 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 22 May 2026.