Evaluating Trop2-ADC treatment for advanced triple-negative breast cancer
Randomized Controlled Clinical Study of Efficacy and Safety of Trop2-ADC Monotherapy or Combination Immunotherapy Strategies in the Treatment of Advanced Triple-negative Breast Cancer
This study is testing a new treatment called Trop2-ADC, alone or with other therapies, to see if it helps people with advanced triple-negative breast cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | chemotherapy, Gosituzumab, immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06851299 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized controlled study aims to assess the efficacy and safety of Trop2-ADC monotherapy and various combination therapies in patients with advanced triple-negative breast cancer. Participants will receive treatment with a Trop-2-targeting antibody-drug conjugate (ADC) either alone or in combination with immunotherapy and anti-angiogenic agents. The study will evaluate treatment efficacy over three months, focusing on overall response rates and monitoring for potential adverse events. Regular assessments will include imaging and histopathological analysis to ensure patient safety and treatment effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adult female patients aged 18-70 with metastatic triple-negative breast cancer and limited prior therapies.
Not a fit: Patients with more than two previous lines of therapy for metastatic disease or those with significant unresolved treatment-related toxicity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new effective treatment options for patients with advanced triple-negative breast cancer.
How similar studies have performed: Other studies have shown promise with similar approaches using antibody-drug conjugates and immunotherapy in treating breast cancer, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\) adult female patients (aged 18-70 years) with metastatic triple negative breast cancer confirmed by pathology or imaging; * 2\) no more than two previous lines of therapy for metastatic disease; * 3\) ECOG performance status ≤2 and expected survival time ≥ 3 months; * 4\) At least one measurable lesion on imaging within 2 weeks before enrollment; Or simple bone metastases; * 5\) Prior treatment-related toxicity at enrollment had to be resolved to NCI CTCAE version 5.0 ≤ grade 1 (excluding alopecia or any other toxicity deemed by the investigator to be of no risk to patient safety) * 6\) adequate bone marrow reserve: a. White blood cell count (WBC) ≥3.0×10\^9 / L, b. Neutrophil count (ANC) ≥1.5×10\^9 / L, c. Platelet count (PLT) ≥70×10\^9 / L * 7\) liver, kidney and heart function tests were basically normal (according to the normal values of the laboratories in the study center) : a. Total bilirubin (TBIL) ≤3× upper limit of normal value (ULN), b. alanine aminotransferase and aspartate aminotransferase (ALT/AST) ≤2.5×ULN (≤5xULN in patients with liver metastases), c. Total bilirubin (TBIL) ≤3× upper limit of normal value (ULN), B. alanine aminotransferase and aspartate aminotransferase (Alt /AST) ≤2.5×ULN (≤5xULN in patients with liver metastases). Serum creatinine ≤1.5×ULN or creatinine clearance (Ccr) ≥60 ml/min; d. Left ventricular ejection fraction (LVEF) ≥ 55%, e. QTcF(Fridericia correction) ≤ 470 ms. * 8\) understood the study process and volunteered to participate in the study. Informed consent was signed. Exclusion Criteria: * 1\) patients with a known allergy to the active ingredient or other ingredient of the study drug. * 2\) patients with known resistance to trop2-ADC drugs. 、 * 3\) receiving radiotherapy, chemotherapy, or endocrine therapy within 4 weeks before enrollment, or participating in any interventional drug clinical trial; * 4\) pregnant or lactating women or women of childbearing age who refused to use effective contraception during the study period. * 5\) patients with severe cardiac disease or discomfort expected to be unable to tolerate chemotherapy, including but not limited to: fatal arrhythmia or higher grade atrioventricular block, unstable angina pectoris, clinically significant valvular heart disease, transmural myocardial infarction on ECG, uncontrolled hypertension; * 6\) any other condition considered by the investigator to be inappropriate for participation in the study, a concomitant disease or condition that could interfere with participation in the study, or any serious medical disorder that could affect the safety of the subject (e.g., uncontrolled heart disease, hypertension, active or uncontrolled infection, active hepatitis B virus infection)；
Where this trial is running
Guangzhou, Guangdong
- Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China; — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Zhao JL Professor
- Email: zhaojianli1988@126.com
- Phone: +86 15920589334
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.