A Clinical Trial of SHR-A1811 in the Treatment of Triple-negative Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-A1811 for Injection, SHR-1316 Injection, Toripalimab Injection, Paclitaxel for Injection.
- Who it may be relevant to
- Registry conditions: PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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).
Interventions
- Drug SHR-A1811 for Injection
SHR-A1811 for injection. - Drug SHR-1316 Injection
SHR-1316 injection. - Drug Toripalimab Injection
Toripalimab injection. - Drug Paclitaxel for Injection
Paclitaxel for injection.
Primary outcome measures
- Progression free survival (PFS) [Time frame: An average of 3 year.]
Secondary outcome measures (6)
- Overall response (OS) rate evaluated by investigators [Time frame: An average of 3 year.]
- Clinical benefit rate (CBR) evaluated by investigators [Time frame: An average of 3 year.]
- Duration of response (DoR) evaluated by investigators [Time frame: An average of 3 year.]
- Progression-free survival on next-line therapy (PFS2) evaluated by investigators [Time frame: An average of 3 year.]
- Adverse events (AEs) [Time frame: An average of 3 year.]
- Serious adverse events (SAEs) [Time frame: An average of 3 year.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Peking University Cancer Hospital — Beijing
- Cancer Hospital，Fudan University — Shanghai
Identifiers
NCT: NCT07111832 · SHR-A1811-313