A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer
Recruiting
Phase 3Interventional Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
5,500 (estimated)
Sponsor
Shandong Suncadia Medicine Co., Ltd. · Industry
Who this trial is looking for
This trial is looking for women with early breast cancer who have had some prior treatment. Participants will receive HRS-8080 and be monitored for their health and treatment response.
Are You a Good Fit for This Trial?
You may be able to join if
I am a female aged 18 to 75 years.
I have been diagnosed with early breast cancer and have had 2 to 5 years of prior treatment.
I do not have any evidence of cancer spread after my surgery.
I have good overall health (ECOG performance status of 0 or 1).
I am willing to use non-hormonal contraception if needed.
I have no unresolved severe side effects from earlier cancer treatments.
I have given my written consent to participate.
I can attend all required visits and tests.
You may not be able to join if
I have metastatic breast cancer.
I have a history of any other cancer in the last 5 years.
I have severe lung disease.
I have had major surgery within the last 4 weeks.
I have an infectious disease like HIV or active hepatitis.
I have poor heart health.
I have a drug allergy.
I am currently breastfeeding or have had a baby in the last year.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The study is being conducted to evaluate the efficacy and safety of HRS-8080 in patients with intermediate or high risk early breast cancer.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Female patients aged ≥ 18 and ≤ 75 years. Premenopausal patients must meet the eligibility of LHRH agonist therapy during the study period.
2. Histologically confirmed invasive breast cancer by postoperative pathology, having received at least 2 years, but no more than 5 year…
Inclusion Criteria:
1. Female patients aged ≥ 18 and ≤ 75 years. Premenopausal patients must meet the eligibility of LHRH agonist therapy during the study period.
2. Histologically confirmed invasive breast cancer by postoperative pathology, having received at least 2 years, but no more than 5 years, of adjuvant endocrine therapy.
3. No evidence of recurrent or metastatic disease after surgery.
4. ECOG performance status of 0 or 1.
5. Adequate organ and bone marrow function.
6. 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.
7. Any acute toxicities from previous anti-tumor therapy have resolved to Grade 0-1 (per CTCAE v5.0).
8. 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.
Exclusion Criteria:
1. Tumor clinical stage IV (metastatic) breast cancer.
2. History and/or treatment of any malignancy other than breast cancer within 5 years prior to randomization.
3. History of severe pulmonary disease, such as interstitial lung disease.
4. Concurrent or potential use of any anti-tumor therapy not specified in the study protocol.
5. Major surgical procedure within 4 weeks prior to randomization.
6. HIV infection or known AIDS, active hepatitis B, hepatitis C, or co-infection with hepatitis B and C.
7. Poor cardiac function.
8. Severe infection within 4 weeks prior to randomization.
9. History of drug allergy.
10. History of organ transplantation.
11. History of substance abuse.
12. Women within 1 year postpartum or who are currently breastfeeding.
13. Patients deemed by the investigator as unsuitable for participation in this study.
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