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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibody-Drug Conjugates | Drug | Patients with advanced breast cancer treated with ADCs |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hellenic Cooperative Oncology Group | Athens | 11524 | Greece |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| C000614160 | trastuzumab deruxtecan |
| C000608132 | sacituzumab govitecan |
| ID | Term |
|---|---|
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D011506 |
| Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
| D007155 | Immunologic Factors |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |