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

NCT06504719 | Completed DMC

• 1 other identifier: HE 11 ADC/23
• Study Type: observational
• Target: 312
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Metastatic Cancer

Keywords

Trastuzumab deruxtecan; Sacituzumab govitecan; Efficacy; Safety; Brain metastasis; ILD

Outcome Measures

Primary Outcomes (1)

• The primary endpoint was toxicity rate of each drug

  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 Outcomes (1)

• progression-free survival (PFS)

  From the date of disease progression to the date of death from any cause or last contact, throughout study completion,up to 24 months

Study Arms (1)

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

Interventions

Antibody-Drug Conjugates DRUG

Patients with advanced breast cancer treated with ADCs

Also known as: trastuzumab deruxtecan, Sacituzumab govitecan

Patients treated with trastuzumab deruxtecan or sacituzumab govitecan

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed metastatic/recurrent breast cancer
• 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

Sponsors & Collaborators

• Hellenic Cooperative Oncology Group: lead

Study Sites (1)

Hellenic Cooperative Oncology Group

Athens, 11524, Greece

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis; Brain Neoplasms

Interventions

Immunoconjugates; trastuzumab deruxtecan; sacituzumab govitecan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins; Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: July 17, 2024
• Study Start: January 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: September 15, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)