A Clinical Trial of SHR-A1811 in the Treatment of Triple-negative Breast Cancer

Not Applicable

Not yet recruiting

• Conditions: PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer
• Interventions: Drug: SHR-A1811 for Injection; Drug: Toripalimab Injection; Drug: SHR-1316 Injection; Drug: Paclitaxel for Injection

• Registration Number: NCT07111832
• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Brief Summary

This study is to evaluate the progression-free survival (PFS) of SHR-A1811 combined with SHR-1316 in the first-line treatment of PD-L1-positive locally recurrent unresectable or metastatic triple-negative breast cancer with Toripalimab combined with Nab-paclitaxel, as assessed by blinded independent central review (BICR).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-01
• Study First Submitted QC: 2025-08-01
• Last Update Submitted: 2025-08-01
• Study First Posted: 2025-08-08
• Last Update Posted: 2025-08-08
• Study Start: 2025-09-01
• Primary Completion: 2028-03
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

1. Age 18-75 years old (including both ends), female.
2. Pathologically confirmed locally recurrent unresectable or metastatic triple-negative breast cancer.
3. Expected survival ≥ 12 weeks.
4. Have adequate renal and hepatic function.
5. Patients voluntarily joined the study and signed the informed consent.

Exclusion Criteria

1. Patients with active central nervous system (CNS) metastases who have not undergone surgery or radiotherapy.
2. Have other malignancies within the past 5 years.
3. Presence with uncontrollable third space effusion.
4. Have undergone other anti-tumor treatment within 4 weeks before the first dose.
5. A history of immunodeficiency.
6. Clinically significant cardiovascular diseases.
7. Known or suspected interstitial lung disease.
8. Known hereditary or acquired bleeding tendency.
9. Toxicities from prior anti-tumor therapy that have not recovered to ≤ Grade 1.
10. Known hypersensitivity to any of the study drugs or their excipients, or a history of allergy to humanized monoclonal antibody products.
11. Presence of other severe physical or mental disorders or clinically significant laboratory abnormalities.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR-A1811 and SHR-1316 Group	SHR-A1811 for Injection	-
SHR-A1811 and SHR-1316 Group	SHR-1316 Injection	-
Toripalimab and Nab-paclitaxel Group	Toripalimab Injection	-
Toripalimab and Nab-paclitaxel Group	Paclitaxel for Injection	-

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	An average of 3 year.

Secondary Outcome Measures

Name	Time	Method
Overall response (OS) rate evaluated by investigators	An average of 3 year.
Clinical benefit rate (CBR) evaluated by investigators	An average of 3 year.
Duration of response (DoR) evaluated by investigators	An average of 3 year.
Progression-free survival on next-line therapy (PFS2) evaluated by investigators	An average of 3 year.
Adverse events (AEs)	An average of 3 year.
Serious adverse events (SAEs)	An average of 3 year.

Trial Locations

Locations (2)

Peking University Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Cancer Hospital，Fudan University; 🇨🇳 Shanghai, Shanghai, China