A Multicenter, Prospective, Cohort Study of Trop-2 ADC Combination Therapy for Advanced Triple-negative Breast Cancer

Launched by TIANJIN MEDICAL UNIVERSITY CANCER INSTITUTE AND HOSPITAL · Mar 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for women with advanced triple-negative breast cancer (TNBC), which is a type of breast cancer that does not have three common hormone receptors. The researchers want to find out if combining a drug called Trop-2 ADC with other therapies, such as immunotherapy (which helps the immune system fight cancer) and anti-angiogenesis drugs (which prevent tumors from growing new blood vessels), can effectively treat this condition. The trial is currently recruiting participants who are between 18 and 70 years old and have been diagnosed with TNBC that has either spread to other parts of the body or returned after earlier treatments.

To be eligible for the trial, participants should have already undergone at least one type of chemotherapy and have measurable cancer lesions. They should not have received immunotherapy or anti-angiogenic treatments before, and they must be in relatively good health overall. During the study, participants can expect to receive the new treatment and undergo regular evaluations to monitor their health and response to the therapy. The study will also include follow-ups to assess safety and effectiveness, helping researchers gather important information about this new combination treatment.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged between 18 and 70 years.
• • 2. Histologically confirmed triple-negative invasive breast cancer, defined as immunohistochemical detection of ER \< 10%, PR \< 10%, HER2 0-1+ or HER2 2+ with negative FISH or CISH results, in accordance with the 2018 ASCO-CAP HER2-negative identification guidelines.
• • 3. Patients with locally advanced or metastatic breast cancer who have undergone radical surgery; patients received at least one but no more than two lines of chemotherapy in the advanced treatment phase. Early-stage triple-negative breast cancer patients who experienced disease progression within one year after neoadjuvant or adjuvant therapy are also eligible.
• • 4. No prior use of immunotherapy or anti-angiogenic drugs.
• • 5. At least one measurable lesion based on RECIST 1.1 criteria.
• • 6. No contraindications to chemotherapy, immunotherapy, or anti-angiogenic therapy.
• • 7. Stable or asymptomatic brain metastases are permitted.
• • 8. ECOG Performance Status (PS) score of 0-2; predicted survival exceeding 12 weeks.
• • 9. All acute toxicities from previous anticancer therapies must have resolved to Grade ≤1 per protocol criteria (excluding alopecia) before screening.
• • 10. Women of childbearing potential must agree to use medically approved contraception during treatment and for at least three months post-treatment.
• • 11. Adequate organ function, meeting the following criteria: Hemoglobin ≥90 g/L without transfusion within 14 days; Absolute Neutrophil Count (ANC) ≥1.5×10\^9/L; Platelets ≥75×10\^9/L; Total Bilirubin ≤1.5×ULN; AST and ALT ≤3×ULN (≤5×ULN if liver metastasis present); Serum Creatinine ≤1×ULN; Left Ventricular Ejection Fraction (LVEF) ≥50%.
• • 12. Participants were voluntarily enrolled in this study, demonstrated excellent adherence, and actively participated in safety and survival follow-up assessments.
• Exclusion Criteria:
• • 1. Uncontrolled central nervous system metastasis (symptomatic or requiring glucocorticoids or mannitol for symptom management);
• • 2. Symptomatic third-space effusions, including pericardial, pleural, and peritoneal effusions, that cannot be adequately managed by drainage or other therapeutic interventions;
• • 3. Participation in another clinical trial within 30 days prior to enrollment;
• • 4. History of other malignancies within the past 5 years, excluding adequately treated cervical carcinoma in situ, skin squamous cell carcinoma, thyroid carcinoma, or controlled basal cell carcinoma;
• • 5. Uncontrolled cardiac conditions, such as: (1) heart failure classified as NYHA class II or higher; (2) unstable angina; (3) myocardial infarction within the past year; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) QTc interval greater than 470 ms;
• • 6. Arterial or venous thrombotic events within 24 weeks preceding informed consent, including cerebrovascular accidents (e.g., transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.
• • 7. Within 24 weeks prior to signing the informed consent form (ICF), a history of any of the following conditions: peptic ulcer, gastrointestinal perforation, corrosive esophagitis or gastritis, inflammatory bowel disease, diverticulitis, abdominal fistula, tracheoesophageal fistula, or intra-abdominal abscess.
• • 8. Presence of factors that significantly impair oral drug absorption, such as inability to swallow, chronic diarrhea, or intestinal obstruction.
• • 9. Patients with a documented history of allergy may have potential hypersensitivity or intolerance to gozzatuzumab, toripalimab, bevacizumab, or anlotinib.
• • 10. Active infection with human immunodeficiency virus (HIV), active hepatitis B (hepatitis B surface antigen positive and HBV DNA ≥500 IU/ml), or hepatitis C (hepatitis C antibody positive and detectable HCV RNA).
• • 11. Pregnant women, lactating women, fertile women with a positive baseline pregnancy test, or women of childbearing age who are unwilling to use effective contraception for the duration of the trial.
• • 12. Presence of concomitant diseases (e.g., poorly controlled hypertension, severe diabetes, neurological or psychiatric disorders) or any other condition that, in the investigator's judgment, could compromise subject safety, confound study results, or prevent subjects from completing the study.