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Compares treatment options for Breast Cancer
Official title A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer
ClinicalTrials.gov ID: NCT07349069
What this study is testing
What is HRS-8080 Tablets?
HRS-8080 Tablets is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is being conducted to evaluate the efficacy and safety of HRS-8080 in patients with intermediate or high risk early breast cancer.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- 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...
- No evidence of recurrent or metastatic disease after surgery.
- ECOG performance status of 0 or 1.
- Adequate organ and bone marrow function.
You likely can't join if
- 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.
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China; Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.