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

Inclusion Criteria:

• The participants voluntarily participate in the study and sign an informed consentform.

• Age: 18-75 years old; Eastern Cooperative Oncology Group (ECOG) score: ≤1 point;Expected survival period exceeds 3 months.

• Breast cancer patients diagnosed as HER2 negative by pathology, with evidence oflocal recurrence or distant metastasis are not suitable for surgery or radiationtherapy aimed at healing.

• Sufficient tumor tissue samples must be available for HER2 evaluation bypathologists at the main research center.

• The participants's previous treatment needs to meet the following criteria: failureafter receiving at least first-line systemic chemotherapy during the recurrence /metastasis stage (for hormone receptor positive participants, failure afterreceiving cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors combined withendocrine therapy during the recurrence/metastasis stage.

• There exists disease progression or intolerance during or after the most recenttreatment before enrollment.

• According to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 standard,there should be at least one measurable lesion.

• The main organ functions well and meets certain standards.

• Female participants of childbearing age should agree to use contraceptive measuresduring the study period and within 6 months after the end of the study; within 7days prior to enrollment, the serum pregnancy test was negative and must be a nonlactating subject; male participants should agree to adopt avoidance measures duringthe study period and within 6 months after the end of the study period.

Exclusion Criteria:

• Concomitant diseases and medical history:

1. Have experienced or currently suffer from other malignant tumors within 5 yearsprior to the first medication use;

2. Uncontrollable toxic reactions above CTCAE level 1 caused by any previoustreatment;

3. Received significant surgical treatment or significant traumatic injury within 28 days prior to the first medication use;

4. Long term unhealed wounds or fractures;

5. Participants who have a history of interstitial lung disease/pneumonia (noninfectious) requiring steroid intervention treatment in the past, or currentlyhave interstitial lung disease/pneumonia, or whose screening imaging suggestssuspected interstitial lung disease/pneumonia and cannot be ruled out;

6. An arterial/venous thrombotic event occurred within 6 months prior to the firstmedication use;

7. Individuals with a history of psychiatric drug abuse who are unable to quit orhave mental disorders;

8. Subjects with any severe and/or uncontrolled diseases. Rheumatoid arthritiswith joint function activity graded as Grade IV or requiring wheelchair or bedrest.

• Tumor related symptoms and treatment:

1. Participants who have received other anti-tumor drug treatments such aschemotherapy, curative radiotherapy, or immunotherapy within 4 weeks before thefirst medication, or who are still within the 5 half-lives of the drug (whichever is the shortest); Participants who have previously received localradiotherapy;

2. Received endocrine therapy or traditional Chinese patent medicines and simplepreparations with anti-tumor indications specified in the National MedicalProducts Administration (NMPA) approved drug directions within 2 weeks beforethe first drug use;

3. Imaging shows that the tumor has invaded important blood vessels, or theresearcher determines that the tumor is highly likely to invade important bloodvessels and cause fatal massive bleeding during subsequent studies;

4. Uncontrollable pleural effusion, ascites, and moderate or higher amounts ofpericardial effusion that require repeated drainage;

5. Known presence of cancerous meningitis or clinically active central nervoussystem metastasis;

6. Severe bone damage caused by tumor bone metastasis. Suffering from lungdiseases that have been determined by the researcher to be unsuitable forparticipation in this study.

• Individuals who are known to be allergic to the investigational drug or itsexcipients, or allergic to humanized monoclonal antibody products.

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

• According to the judgment of the researchers, there are situations that seriouslyendanger the safety of the subjects or affect their completion of the study.