Recruiting NCT07349069
A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRS-8080 Tablets, Letrozole tablets, Tamoxifen Citrate Tablets, Anastrozole Tablets.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
The study is being conducted to evaluate the efficacy and safety of HRS-8080 in patients with intermediate or high risk early breast cancer.
Interventions
- Drug HRS-8080 Tablets
HRS-8080 tablets. - Drug Letrozole tablets
Letrozole tablets. - Drug Tamoxifen Citrate Tablets
Tamoxifen Citrate tablets. - Drug Anastrozole Tablets
Anastrozole tablets. - Drug Exemestane tablets
Exemestane tablets.
Primary outcome measures
- 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.]
Secondary outcome measures (3)
- 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.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- The First Affiliated Hospital of Nanjing Medical University — Nanjing
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT07349069 · HRS-8080-305