Clinical trial · Interventional
A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer
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
NCT07024173CI-TRIAL-00101648recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anastrozole Tablets | Drug | Anastrozole | ALIAS |
| Everolimus Tablets | Drug | Everolimus | ALIAS |
| Exemestane tablets | Drug | Exemestane | ALIAS |
| Fulvestrant injection | Drug | Fulvestrant | ALIAS |
| HRS-8080 Tablet | Drug | — | UNRESOLVED |
| Letrozole Tablets | Drug | Letrozole | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- HRS-8080 Group
- interventionNames
- Drug: HRS-8080 Tablet
- type
- ACTIVE_COMPARATOR
- label
- Fulvestrant Group
- interventionNames
- Drug: Fulvestrant injection
- type
- ACTIVE_COMPARATOR
- label
- Exemestane in combination with Everolimus Group
- interventionNames
- Drug: Exemestane tablets
- Drug: Everolimus Tablets
- type
- ACTIVE_COMPARATOR
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women aged 18 to 75 years old (including both values). 2. ECOG Physical Strength Status (PS) : 0 to 1 point. 3. Patients with locally advanced or metastatic breast cancer confirmed by histology. 4. Patients previously received 1-2 lines of endocrine therapy. 5. Expected survival \> 6 months. 6. The functional level of the organs must meet the requirements. 7. Subjects that 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. Exclusion Criteria: 1. Patients with rapid disease progress and investigators determine that endocrine therapy is not suitable or tolerant. 2. A history of severe clinical cardiovascular diseases. 3. Patients with uncontrollable tumor-related pain as judged by investigators. 4. Severe infection exists within 4 weeks before the first study administration. 5. Patients with clinically significant endometrial abnormalities. 6. Untreated active hepatitis. 7. Patients known to be allergic to HRS-8080 components. 8. Pregnant and lactating women, or those planning to become pregnant during the study period.
References
Publications (0)
Data not yet available
No reference posted for this study.