Clinical trial · Interventional
A Trial of HRS-8080 Tablets in Metastatic or Local Advanced Breast Cancer of Adults
A Single-arm, Open-label and Multi-center Phase I Study on Safety, Tolerance and Pharmacokinetics of HRS-8080 Tablets Monotherapy and Combined With Other Anti-cancer Therapy in Patients With Metastatic or Local Advanced Breast Cancer
- 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)
The study is being conducted to evaluate the tolerance, and safety of HRS-8080 tablets monotherapy and combined with other anti-cancer therapy for metastatic or local advanced breast cancer in adults. To explore the reasonable dosage of HRS-8080 tablets for metastatic or local advanced breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic or Local Advanced Breast Cancer of Patients | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HRS-8080 tablets、SHR 6390 tablets、Abemaciclib、Everolimus | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Group
- description
- Firstly Dose Escalation and Dose Expansion of HRS-8080 monotherapy should be conducted. After RP2D and MTD of the HRS-8080 monotherapy were confirmed, Dose Escalation and Dose Extension of HRS-8080 in combination with other anti-cancer treatment would be completed, including SHR 6390, or Abemaciclib, or Everolimus.
- interventionNames
- Drug: HRS-8080 tablets、SHR 6390 tablets、Abemaciclib、Everolimus
Primary outcomes (3)
- measure
- Maximum tolerated dose
- timeFrame
- up to 28 days
- description
- The Maximum tolerated dose of HRS-8080 monotherapy or in combination with SHR-6390 / Abemaciclib / Everolimus
- measure
- Recommended phase II dose
- timeFrame
- up to 28 days
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. ECOG performance status score: 0-1; 2. Histopathologically documented local advanced or metastatic breast cancer ; 3. Female of not childbearing potential must the related requirement; 4. During or after the last systematic therapy before enrolment, disease progression occurred with clinical or radiographical documentation; 5. Adequate organ functions as defined; 6. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study. Exclusion Criteria: 1. For the case of symptomatic visceral metastasis, the investigators judged that it was not suitable to use relevant treatment; 2. patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, spinal cord compression, or patients with a history of primary tumors of the central nervous system ; 3. History of clinically significant cardiovascular or cerebrovascular diseases; 4. The subject has one of many factors affecting oral drugs; 5. Active infection or fever with unknown cause \> 38.5 °C; 6. Active autoimmune diseases, History of immunodeficiency, including positive HIV serum test result and other acquired or congenital immunodeficiency diseases, or history of organ transplantation; 7. Known history of allergy to study drug ingredients.
References
Publications (0)
Data not yet available