Safety and Efficacy Real-world Data of Trastuzumab Deruxtecan and Sacituzumab Govitecan

September 9, 2025 updated by: Hellenic Cooperative Oncology Group

Safety and Efficacy Real-world Data of Trastuzumab Deruxtecan and Sacituzumab Govitecan in Patients With Advanced Breast Cancer

The study aims to evaluate real-world efficacy and toxicity data of treatment with Trastuzumab deruxtecan (T-DXd), a HER2-targeting ADC and sacituzumab govitecan (SG), a TROP-2-targeting ADC in pretreated patients with advanced breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Antibody-drug conjugates (ADCs) have significantly changed the therapeutic landscape of advanced breast cancer. Trastuzumab deruxtecan (T-DXd), a HER2-targeting ADC and sacituzumab govitecan (SG), a TROP-2-targeting ADC, recently demonstrated superior efficacy over standard of care treatments depending on breast cancer subtype. The study aims to evaluate real-world efficacy and toxicity data of treatment with T-DXd and SG in pretreated patients with advanced breast cancer.

This study includes a retrospective/prospective multicenter review of medical records of patients with advanced breast cancer who received treatment with T-DXd and SG at Departments of Oncology, affiliated with the Hellenic Cooperative Oncology Group (HeCOG).

Study Type

Observational

Enrollment (Actual)

312

Contacts and Locations

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

Study Locations

  • Greece
      • Athens, Greece, 11524
        • Hellenic Cooperative Oncology Group

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

Sampling Method

Non-Probability Sample

Study Population

This study includes patients with histologically confirmed metastatic/recurrent breast cancer. Patients need to have received treatment with T-DXd and/or SG at Departments of Oncology in Departments of Oncology associated with the Hellenic Cooperative Oncology Group (HeCOG). Eligible patients are 18 years or older, diagnosed with triple-negative (TNBC), HER2-positive and/or hormone receptor positive advanced breast cancer, who received an ADC at any of line of treatment. Patients who received at least one cycle of T-DXd and/or SG are included. Immunohistochemical markers may be determined locally. Treatment with T-DXd and SG is administered per national guidelines.

Description

Inclusion Criteria:

  • Histologically confirmed metastatic/recurrent breast cancer
  • 18 years of age
  • Triple-negative (TNBC), HER2-positive and/or hormone receptor positive advanced breast cancer
  • Treatment with an ADC at any of line of treatment
  • Treatment with at least one cycle of T-DXd and/or SG

Exclusion Criteria:

  • NA

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients treated with trastuzumab deruxtecan or sacituzumab govitecan
Patients with TNBC, HER2-positive and/or hormone receptor positive advanced breast treated with trastuzumab deruxtecan or sacituzumab govitecan
Drug: Antibody-Drug Conjugates
Patients with advanced breast cancer treated with ADCs
Other Names:
  • trastuzumab deruxtecan
  • Sacituzumab govitecan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary endpoint was toxicity rate of each drug
Time Frame: From the initiation of ADC to the date of discontinuation (due to any reason), first documented progression, death from any cause or last contact, throughout study completion, up to 24 months
Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0)
From the initiation of ADC to the date of discontinuation (due to any reason), first documented progression, death from any cause or last contact, throughout study completion, up to 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
progression-free survival (PFS)
Time Frame: From the date of disease progression to the date of death from any cause or last contact, throughout study completion,up to 24 months
From the date of disease progression to the date of death from any cause or last contact, throughout study completion,up to 24 months

Collaborators and Investigators

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

Sponsor

Hellenic Cooperative Oncology Group

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 (Actual)

January 1, 2023

Primary Completion (Actual)

June 1, 2024

Study Completion (Actual)

September 1, 2024

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

July 15, 2024

First Posted (Actual)

July 17, 2024

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 9, 2025

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE 11 ADC/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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