SHR-1811 Combined With Carboplatin in the Treatment of Advanced Breast Cancer With HER2 Expression

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorAnhui Provincial Cancer Hospital

About this trial

To find the optimal dose of carboplatin combined with SHR-A1811 in her2-expressed metastatic breast cancer

Eligibility criteria

Qualifiers

Women aged 18 to 75 (inclusive of both values).

Unresectable or metastatic breast cancer with HER2 positive (IHC 3+ or IHC 2+/ISH+), low HER2 expression (IHC 1+ or IHC 2+/ISH-), or ultra-low HER2 expression (IHC 0 with membrane staining) confirmed by histology or cytology.

Failure of standard treatment in the advanced stage.

For HER2+ metastatic breast cancer, one can have received second-generation ADC (such as T-DM1) treatment, but cannot have received third-generation ADC (such as T-DXd) treatment. For HER2 low expression or HER2 ultra-low expression metastatic breast cancer, it is necessary to meet the requirement that no ADC drug treatment has been received.

Disqualifiers

Have had other malignant tumors within the past 5 years, excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.

There is effusion in the third space that cannot be controlled by methods such as drainage (such as a large amount of ascites, pleural effusion, and pericardial effusion).

Clinical researchers who have received surgical treatment (referring to major surgeries for cancer), radiotherapy, chemotherapy, immunotherapy, molecular targeted therapy, biological therapy or other drugs within 4 weeks before the first medication; Those who have received endocrine therapy within two weeks before the first medication.

Patients with HER2+ metastatic breast cancer have received treatment with third-generation ADCs (such as T-DXd); Patients with HER2 low-expression or ultra-low-expression metastatic breast cancer who have received any ADC drug treatment.

Trial design

Treatments tested in this trial

  • SHR- A1811

Treatment groups

18 Participants
are divided into 1 treatment group