The Clinical Trial of TQB2102 for Injection Against Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer

Required: HER2 (ERBB2) negative

HER2 negative by pathology

Must have received: systemic chemotherapy — recurrence/metastasis stage

failure after receiving at least first-line systemic chemotherapy during the recurrence /metastasis stage

Must have received: CDK4/6 inhibitor combined with endocrine therapy — recurrence/metastasis stage

for hormone receptor positive participants, failure after receiving cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors combined with endocrine therapy during the recurrence/metastasis stage

Cannot have received: anti-tumor drug treatments such as chemotherapy, curative radiotherapy, or immunotherapy

Participants who have received other anti-tumor drug treatments such as chemotherapy, curative radiotherapy, or immunotherapy within 4 weeks before the first medication, or who are still within the 5 half-lives of the drug (whichever is the shortest)

Cannot have received: local radiotherapy

Participants who have previously received local radiotherapy

Cannot have received: endocrine therapy

Received endocrine therapy ... within 2 weeks before the first drug use

Cannot have received: traditional Chinese patent medicines and simple preparations with anti-tumor indications

Received ... traditional Chinese patent medicines and simple preparations with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug directions within 2 weeks before the first drug use

Cannot have received: other anti-tumor clinical trial drugs

Individuals who have participated in and used other anti-tumor clinical trial drugs within 4 weeks prior to the first medication use