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NCT Number: NCT07111832

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

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).

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Peking University Cancer Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

SHR-A1811 for Injection

Drug

SHR-A1811 for injection.

SHR-1316 Injection

Drug

SHR-1316 injection.

Toripalimab Injection

Drug

Toripalimab injection.

Paclitaxel for Injection

Drug

Paclitaxel for injection.

Primary outcomes

  1. Progression free survival (PFS)

    Time frame: An average of 3 year.

Secondary outcomes

  1. Overall response (OS) rate evaluated by investigators

    Time frame: An average of 3 year.

  2. Clinical benefit rate (CBR) evaluated by investigators

    Time frame: An average of 3 year.

  3. Duration of response (DoR) evaluated by investigators

    Time frame: An average of 3 year.

  4. Progression-free survival on next-line therapy (PFS2) evaluated by investigators

    Time frame: An average of 3 year.

  5. Adverse events (AEs)

    Time frame: An average of 3 year.

  6. Serious adverse events (SAEs)

    Time frame: An average of 3 year.

Study contacts

Contact information is provided by the study sponsor or research team.

Tingting Lei

CONTACT

[email protected]

+86-0518-82342973

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

A Phase III, Multicenter, Randomized, Open-label, Active-controlled Study of SHR-A1811 Plus SHR-1316 Versus Toripalimab Plus Nab-paclitaxel in PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 8, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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