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Completed

NCT Number: NCT06504719

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

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.

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Key information

Conditions

Breast Cancer Brain Diseases Brain Neoplasms Breast Diseases Breast Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hellenic Cooperative Oncology Group

Athens, 11524, Greece

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antibody-Drug Conjugates

Drug

Patients with advanced breast cancer treated with ADCs

Other names: trastuzumab deruxtecan, Sacituzumab govitecan

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hellenic Cooperative Oncology Group

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 17, 2024
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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