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.

February 25, 2025 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective, multicenter, randomized controlled study aims to evaluate the 3-month treatment efficacy (ORR) of three therapeutic strategies-ADC monotherapy, ADC in combination with immunotherapy, and ADC in combination with immunotherapy and anti-angiogenesis-in patients with advanced breast cancer, and to assess potential adverse events related to the treatment regimens. Participants will receive treatment with a Trop-2-targeting ADC drug containing a TOP1 inhibitor (such as Gosituzumab or SKB264), in accordance with the defined protocol. Regular assessments will include imaging, histopathological analysis, and safety monitoring. The objective of this study is to provide novel treatment strategies for triple-negative breast cancer by evaluating the efficacy and safety of trop2-ADC+ immunotherapy + antiangiogenic agents and trop2-ADC+ antiangiogenic agents versus trop2-ADC monotherapy in patients with metastatic triple-negative breast cancer (mTNBC).

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China;
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)；

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Accept ADC monotherapy
Drug: trop2-ADC
Accept ADC monotherapy
Experimental: Accept ADC combined with anti-angiogenic drug
Drug: ADC +anti-angiogenic drug
Accept ADC combined with anti-angiogenic drug
Experimental: Receive ADC in combination with PD1 monoclonal antibody and anti-angiogenic drug
Drug: ADC + PD1 monoclonal antibody +anti-angiogenic drug
ADC combined with PD1 monoclonal antibody and anti-angiogenic drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response rate 3 months after treatment (ORR)
Time Frame: Three months after enrollment
Three months after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 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
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
Time Frame: "through study completion, an average of 1 year
The scores of EORTC-c30 scale were compared before and after enrollment.
"through study completion, an average of 1 year
Clinical benefit rate
Time Frame: 3 months after enrollment
3 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

February 29, 2028

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

February 25, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSKY-2025-007-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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