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RecruitingPhase 1, Phase 2NCT06222879

Study of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer

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Trial Parameters

ConditionBreast Cancer
SponsorShandong Suncadia Medicine Co., Ltd.
Study TypeINTERVENTIONAL
PhasePhase 1, Phase 2
Enrollment350
SexFEMALE
Min Age18 Years
Max Age75 Years
Start Date2024-02-20
Completion2026-10-31
Interventions
HRS-8080; SHR-A1811HRS-8080; SHR-A2009SHR-A2009; SHR-1316

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Brief Summary

This study is designed to determine if treatments with the combination of HRS-8080 and SHR-A1811, the combination of HRS-8080 and SHR-A2009, the combination of SHR-A2009 and SHR-1316 are safe, tolerable, and has anti-cancer activity in patients with unresectable or metastatic breast cancer.

Eligibility Criteria

Inclusion Criteria: 1. Females aged 18-75 years old (both ends inclusive); 2. ECOG performance status (PS) 0-1 points; 3. Patients with metastatic or locally advanced breast cancer confirmed by histology(ER positive, HER2 positive/negative,or triple negative breast cancer). 4. Tumor tissue samples must be provided for detection of tumor markers; 5. Menopausal state; 6. Disease progression confirmed by imaging during or after the last systemic treatment before enrollment; 7. There must be at least one measurable extracranial lesion that complies with RECIST v1.1; 8. Expected survival \>3 months; 9. Good functional level of the organs ; 10. Female subjects with childbearing potential must agree to use highly effective contraceptive measures during the study treatment period and within 7 months after the end of the study treatment period; female subjects with childbearing potential must agree to use serum serum within 7 days before study enrollment. The HCG test must be negative and the p

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