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

Active, not recruiting

• Conditions: Metastatic Cancer; Breast Cancer
• Interventions: Drug: Antibody-Drug Conjugates

• Registration Number: NCT06504719
• Lead Sponsor: Hellenic Cooperative Oncology Group

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.

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 Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2024-04-09
• Primary Completion: 2024-06-01
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-15
• Last Update Submitted: 2024-07-15
• Study First Posted: 2024-07-17
• Last Update Posted: 2024-07-17
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 312

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients treated with trastuzumab deruxtecan or sacituzumab govitecan	Antibody-Drug Conjugates	Patients with TNBC, HER2-positive and/or hormone receptor positive advanced breast treated with trastuzumab deruxtecan or sacituzumab govitecan

Primary Outcome Measures

Name	Time	Method
The primary endpoint was toxicity rate of each drug	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hellenic Cooperative Oncology Group; 🇬🇷 Athens, Greece