A Trial of HRS-8080 Tablets in Metastatic or Local Advanced Breast Cancer of Adults

Shandong Suncadia Medicine

Status and phase: Invitation-only; Phase 1

Conditions: Metastatic or Local Advanced Breast Cancer of Patients

Treatments: Drug: HRS-8080 tablets、SHR 6390 tablets、Abemaciclib、Everolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT05189717

HRS-8080-I-101

Details and patient eligibility

About

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.

Enrollment: 156 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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156 participants in 1 patient group

Single Group

Experimental 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.

Treatment:

Drug: HRS-8080 tablets、SHR 6390 tablets、Abemaciclib、Everolimus