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

NCT ID: NCT06504719

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

312 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-09-01

Brief Summary

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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

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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).

Conditions

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Breast Cancer Metastatic Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Antibody-Drug Conjugates

Intervention Type DRUG

Patients with advanced breast cancer treated with ADCs

Interventions

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Antibody-Drug Conjugates

Patients with advanced breast cancer treated with ADCs

Intervention Type DRUG

Other Intervention Names

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trastuzumab deruxtecan Sacituzumab govitecan

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hellenic Cooperative Oncology Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hellenic Cooperative Oncology Group

Athens, , Greece

Site Status

Countries

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Greece

Other Identifiers

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HE 11 ADC/23

Identifier Type: -

Identifier Source: org_study_id

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