The Clinical Study of the Efficacy and Safety of Trop2-ADC Monotherapy or Combination Immunotherapy Strategy in the Treatment of Advanced Triple-negative Breast Cancer.

NCT06851299 | Recruiting Phase 2

• 1 other identifier: SYSKY-2025-007-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, multicenter, randomized controlled study aimed at evaluating the efficacy and safety of Trop2-ADC monotherapy or immune combination strategy in the treatment of advanced triple-negative breast cancer.

Conditions

Metastatic Triple-negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate 3 months after treatment (ORR)

  Three months after enrollment

Secondary Outcomes (3)

• Overall survival (OS)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

• living quality

  "through study completion, an average of 1 year

• Clinical benefit rate

  3 months after enrollment

Study Arms (3)

Accept ADC monotherapy

ACTIVE COMPARATOR

Drug: trop2-ADC

Accept ADC combined with anti-angiogenic drug

EXPERIMENTAL

Drug: ADC +anti-angiogenic drug

Receive ADC in combination with PD1 monoclonal antibody and anti-angiogenic drug

EXPERIMENTAL

Drug: ADC + PD1 monoclonal antibody +anti-angiogenic drug

Interventions

trop2-ADC DRUG

Accept ADC monotherapy

Accept ADC monotherapy

ADC +anti-angiogenic drug DRUG

Accept ADC combined with anti-angiogenic drug

Accept ADC combined with anti-angiogenic drug

ADC + PD1 monoclonal antibody +anti-angiogenic drug DRUG

ADC combined with PD1 monoclonal antibody and anti-angiogenic drug

Receive ADC in combination with PD1 monoclonal antibody and anti-angiogenic drug

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) adult female patients (aged 18-70 years) with metastatic triple negative breast cancer confirmed by pathology or imaging;
• \) no more than two previous lines of therapy for metastatic disease;
• \) ECOG performance status ≤2 and expected survival time ≥ 3 months;
• \) At least one measurable lesion on imaging within 2 weeks before enrollment; Or simple bone metastases;
• \) 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)
• \) 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
• \) 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.
• \) understood the study process and volunteered to participate in the study. Informed consent was signed.

You may not qualify if:

• \) patients with a known allergy to the active ingredient or other ingredient of the study drug.
• \) patients with known resistance to trop2-ADC drugs. 、
• \) receiving radiotherapy, chemotherapy, or endocrine therapy within 4 weeks before enrollment, or participating in any interventional drug clinical trial;
• \) pregnant or lactating women or women of childbearing age who refused to use effective contraception during the study period.
• \) 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;
• \) 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)；

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China;

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

arginine decarboxylase

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Zhao JL Professor

CONTACT

+86 15920589334; zhaojianli1988@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 28, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): February 29, 2028
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

CN (1)